SIST EN ISO 13485:2016/A11:2021
(Amendment)Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
Medizinprodukte - Qualitätsmanagementsysteme - Anforderungen für regulatorische Zwecke (ISO 13485:2016)
Dispositifs médicaux - Systèmes de management de la qualité - Exigences à des fins réglementaires (ISO 13485:2016)
Medicinski pripomočki - Sistemi vodenja kakovosti - Zahteve za zakonodajne namene - Dopolnilo A11 (ISO 13485:2016)
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SLOVENSKI STANDARD
SIST EN ISO 13485:2016/A11:2021
01-december-2021
Medicinski pripomočki - Sistemi vodenja kakovosti - Zahteve za zakonodajne
namene - Dopolnilo A11 (ISO 13485:2016)
Medical devices - Quality management systems - Requirements for regulatory purposes
(ISO 13485:2016)
Medizinprodukte - Qualitätsmanagementsysteme - Anforderungen für regulatorische
Zwecke (ISO 13485:2016)
Dispositifs médicaux - Systèmes de management de la qualité - Exigences à des fins
réglementaires (ISO 13485:2016)
Ta slovenski standard je istoveten z: EN ISO 13485:2016/A11:2021
ICS:
03.100.70 Sistemi vodenja Management systems
11.020.01 Vodenje kakovosti in Quality and environmental
ravnanje z okoljem v management in health care
zdravstvu
SIST EN ISO 13485:2016/A11:2021 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 13485:2016/A11:2021
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SIST EN ISO 13485:2016/A11:2021
EUROPEAN STANDARD
EN ISO 13485:2016/A11
NORME EUROPÉENNE
EUROPÄISCHE NORM
September 2021
ICS 03.100.70; 11.040.01
English version
Medical devices - Quality management systems -
Requirements for regulatory purposes (ISO 13485:2016)
Dispositifs médicaux - Systèmes de management de la Medizinprodukte - Qualitätsmanagementsysteme -
qualité - Exigences à des fins réglementaires (ISO Anforderungen für regulatorische Zwecke (ISO
13485:2016) 13485:2016)
This amendment A11 modifies the European Standard EN ISO 13485:2016; it was approved by CEN on 12 April 2021.
CEN and CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for
inclusion of this amendment into the relevant national standard without any alteration. Up-to-date lists and bibliographical
references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to
any CEN and CENELEC member.
This amendment exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN and CENELEC member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.
CEN and CENELEC members are the national standards bodies and national electrotechnical committees of Austria, Belgium,
Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy,
Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia,
Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.
CEN-CENELEC Management Centre:
Rue de la Science 23, B-1040 Brussels
© 2021 CEN/CENELEC All rights of exploitation in any form and by any means Ref. No. EN ISO 13485:2016/A11:2021 E
reserved worldwide for CEN national Members and for
CENELEC Members.
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SIST EN ISO 13485:2016/A11:2021
EN ISO 13485:2016/A11:2021
Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European standard and the
requirements of Regulation (EU) 2017/745 aimed to be covered . 4
Annex ZB (informative) Relationship between this European standard and the
requirements of Regulation (EU) 2017/746 aimed to be covered . 16
2
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SIST EN ISO 13485:2016/A11:2021
EN ISO 13485:2016/A11:2021
European foreword
This document (EN ISO 13485:2016/A11:2021) has been prepared by Technical Committee
CEN/CLC/TC 3 “Quality management and corresponding general aspects for medical devices” the
secretariat of which is held by NEN.
This document amends EN ISO 13485:2016, incorporating corrigenda March 2016, December 2016 and
2018, with a revised European Foreword and European Annexes ZA and ZB.
This Amendment to the European Standard EN ISO 13485:2016 has been prepared under a mandate
given to CEN by the European Commission and the European Free Trade Association, and supports
requirements of EU Regulation(s).
For relationship with EU Regulation(s), see informative Annex ZA, and ZB, which are an integral part of
this document.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN websites.
The following referenced documents are indispensable for the application of this document. For undated
references, the edition of the referenced document (including any amendments) listed below applies. For
dated references, only the edition cited applies. However, for any use of this standard within the meaning
of Annex ZA or ZB, the user should always check that any referenced document has not been superseded
and that its relevant contents can still be considered the generally acknowledged state-of-art.
When an IEC or ISO standard is referred to in the ISO standard text, this should be understood as a
normative reference to the corresponding EN standard, if available, and otherwise to the dated version
of the ISO or IEC standard as listed below.
NOTE The way in which these referenced documents are cited in normative requirements determines the
extent (in whole or in part) to which they apply.
Table – Correlation between normative references and dated EN and ISO standards
Normative references Equivalent dated standard
as listed in Clause 2 of the ISO
EN ISO
standard
ISO 9000:2015 EN ISO 9000:2015 ISO 9000:2015
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia,
Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland,
Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of North
Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United
Kingdom.
3
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SIST EN ISO 13485:2016/A11:2021
EN ISO 13485:2016/A11:2021
Annex ZA
(informative)
Relationship between this European standard and the requirements of
Regulation (EU) 2017/745 aimed to be covered
This European standard has been prepared under a Commission’s standardisation request M/575 of
14.4.2021 to provide one voluntary means of conforming to the requirements of Regulation (EU)
2017/745 of 5 April 2017 concerning medical devices [OJ L 117].
Once this standard is cited in the Official Journal of the European Union under that Regulation, compliance
with the normative clauses of this standard given in Tables ZA.1, ZA.2 or ZA.3 confers, within the limits
of the scope of this standard, a presumption of conformity with the corresponding requirements of that
Regulation, and associated EFTA regulations.
This Annex covers the relationship of this European standard with:
• the general obligations of the manufacturer in Article 10 (Table ZA.1); and,
• the quality management system requirements in the conformity assessment annexes (Annexes IX
and XI) (Table ZA.2 and ZA.3 respectively).
EN ISO 13485:2016 is an adoption of an international standard, ISO 13485:2016, which is intended to be
applicable in jurisdictions all over the world. Therefore, it is not the primary goal of ISO 13485:2016 to
cover exactly the European quality management system requirements. Consequently, for all of the quality
management system requirements, conformity is not entirely achieved by complying only with the
requirements specified in EN ISO 13485. Manufacturers and conformity assessment bodies will need to
integrate the quality management system requirements in the applicable European Regulation into the
processes provided by EN ISO 13485. In addition, the European Regulations require the incorporation of
certain processes in the quality management system, such as clinical evaluation, risk management, post-
market surveillance, and assignment of unique device identification. EN ISO 13485 requires the
integration of these processes into the quality management system in accordance with regulatory
requirements but does not explicitly include the details of the particular European Union regulatory
requirements within the standard. Furthermore, the definitions in applicable regulatory requirements
differ from nation to nation and region to region. As a result, the definitions in this document can differ
in wording from those in European Regulations. For use in support of European requirements, definitions
in the European regulations for medical devices take precedence.
In addition to requirements on the manufacturer’s quality management system, Article 10 and
Annexes IX and XI of the European Regulations include a description of the regulatory processes and
activities undertaken by the notified body, competent authority and European Commission, which are
outside of the scope of EN ISO 13485 and therefore not covered by the standard.
NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk
management process needs to be in compliance with Regulation (EU) 2017/745. This means that risks have to be
‘reduced as far as possible’, ‘reduced to the lowest possible level’, ‘reduced as far as possible and appropriate’,
‘removed or reduced as far as possible’, ‘eliminated or reduced as far as possible’, ’removed or minimized as far as
possible’, or ‘minimized’, according to the wording of the corresponding General Safety and Performance
Requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with General Safety
and Performance Requirements 1, 2, 3, 4, 5, 8, 9, 10, 11, 14, 16, 17, 18, 19, 20, 21 and 22 of the Regulation.
4
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SIST EN ISO 13485:2016/A11:2021
EN ISO 13485:2016/A11:2021
NOTE 3 This Annex ZA is based on normative references according to the table of references in the European
Foreword, replacing the references in the core text.
NOTE 4 When a requirement does not appear in Tables ZA.1, ZA.2 or ZA.3 it means that it is not addressed by
this European Standard.
Table ZA.1 – Correspondence between this European standard and the requirements of Article 10 of
Regulation (EU) 2017/745 [OJ L 117]
Requirements of Article 10 Clause(s) / sub-clause(s) of
Remarks / Notes
of Regulation (EU) 2017/745 this EN
1 4.1, 7.1, 7.2.1 c), 7.2.2 c), 7.3, 7.5 Partially covered. EN ISO 13485 includes
requirements for the QMS, design and
development and manufacturing that
require incorporation of the regulatory
requirements into the quality
management system.
2 7.1 Partially covered. EN ISO 13485 includes
requirements to risk management in
product realization. The detail of the
specific requirements of Annex 1,
Chapter 1 of the Regulation is not stated
explicitly.
3 Not covered. 7.3.7 of EN ISO 13485
requires clinical evaluation in
accordance with applicable regulatory
requirements. The details contained in
Article 61 or Annex XIV are not provided.
st
4, 1 paragraph 4.2.3 Partially covered. EN ISO 13485 requires
that the quality management system
includes one or more files either
containing or referencing documents
generated to demonstrate compliance
with applicable regulatory requirements.
A summary of the types of documents is
provided. All the detail in Annexes II and
III is not provided explicitly.
nd
4, 2 paragraph Not covered. Refers to action by the
European Commission outside the scope
of the standard.
5 4.2.3 Partially covered. EN ISO 13485 requires
that the quality management system
includes one or more files either
containing or referencing documents
generated to demonstrate compliance
with applicable regulatory requirements.
A summary of the types of documents is
provided. All the detail in Annex XIII is
not provided explicitly.
6 Not covered. Preparation of the EU
declaration of conformity is not covered
in EN ISO 13485
7 Not covered. 7.5.8 of EN ISO 13485
includes a requirement to control the
5
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SIST EN ISO 13485:2016/A11:2021
EN ISO 13485:2016/A11:2021
Requirements of Article 10 Clause(s) / sub-clause(s) of
Remarks / Notes
of Regulation (EU) 2017/745 this EN
UDI under the quality management
system. The detail of the system
prescribed in Article 27, and with the
registration obligations referred to in
Articles 29 and 31, are not provided.
st
8, 1 paragraph 4.2.4, 4.2.5, 7.2.3 Partially covered. EN ISO 13485 requires
the retention of documents, including
records, for at least the period specified
by applicable regulatory requirements.
The retention time defined in the
Regulations is not provided explicitly.
nd
8, 2 paragraph 7.2.3 Partially covered. EN ISO 13485 requires
communication with regulatory
authorities in accordance with
applicable regulatory requirements. The
term ‘regulatory authorities’ is used in a
general context and the term competent
authority, as used in the Regulation, is
not explicitly mentioned. The provision
of specific information as detailed in the
Regulation is not stated explicitly.
rd
8, 3 paragraph Not covered.
st st
9, 1 paragraph, 1 sentence 4, 5, 6, 7, 8 Covered. EN ISO 13485 requires the
quality management system to comply
with applicable regulatory requirements
and that production is planned, carried
out, monitored and controlled to ensure
that product conforms to specification
and regulatory requirements.
st nd
9, 1 paragraph, 2 sentence 4.1.4, 4.2.4, 5.6.2, 5.6.3, 7.3.3, Partially covered. EN ISO 13485 includes
7.3.9 general reference to regulatory
requirements and standards as design
and development inputs. Identification
of new or revised regulatory
requirements is identified as an input
into Management Review) and changes
needed as a result of such changes
required as outputs of Management
Review). Change to the medical device is
covered through control of design and
development changes. Common
specifications are not explicitly
mentioned.
rd
9, 1st paragraph, 3 sentence 4.1 Partially covered. EN ISO 13485 requires
that the effectiveness of the quality
management system is maintained and
provides requirements for improvement
processes, including corrective action
and preventive action. There is no
explicit requirement for the quality
management system to be continually
improved.
6
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SIST EN ISO 13485:2016/A11:2021
EN ISO 13485:2016/A11:2021
Requirements of Article 10 Clause(s) / sub-clause(s) of
Remarks / Notes
of Regulation (EU) 2017/745 this EN
nd
9, 2 paragraph 4, 5, 6, 7, 8 Covered.
rd
9, 3 paragraph (a) 4.1.1, 7.3.9 Partially covered. EN ISO 13485 requires
that the organization identifies
applicable regulatory requirements and
incorporates them in its quality
management system. An explicit
requirement for a documented
regulatory strategy is not included.
Control of design and development
changes is explicitly specified.
rd
9, 3 paragraph (b) 4.2.3, 7.2.1c), 7.3.3b), 7.3.4a), Partially covered. EN ISO 13485 includes
7.3.5 a general reference to inclusion of
applicable regulatory requirements and
standards as a design input. The general
safety and performance requirements,
harmonized standards or common
specifications are not mentioned
explicitly.
rd
9, 3 paragraph (c) 5 Covered. EN ISO 13485 defines
responsibilities of top management.
rd
9, 3 paragraph (d) 4.1.5, 6, 7.4.1 Covered. EN ISO 13485 includes specific
requirements for provision of human
resources including competence,
infrastructure, work environment and
contamination control.
rd
9, 3 paragraph (e) 4.1.2, 7.1 Partially covered. EN ISO 13485 includes
requirements to apply a risk-based
approach to the quality management
system and apply risk management in
product realization. The detail of the
specific requirements of Annex 1 of the
Regulation are not detailed specifically.
rd
9,3 paragraph (f) Not covered. EN ISO 13485 requires
clinical evaluation in accordance with
applicable regulatory requirements. The
specific details in Article 61 and
Annex XIV and reference to post market
clinical follow-up (PMCF) are not
included explicitly.
rd
9, 3 paragraph (g) 7.1, 7.3.2, 7.3.8, 7.5.1, 7.5.4 Covered. EN ISO 13485 requires
planning of product realization, planning
of design and development and planning
of production and service provision.
rd
9, 3 paragraph (h) Not covered. EN ISO 13485 includes a
requirement to control the UDI under
the quality management system. The
detail of the system prescribed in the
Regulation is not specified explicitly.
rd
9, 3 paragraph (i) 8.2.1, 8.5.1 Partially covered. EN ISO 13485 requires
a system of post market surveillance
7
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SIST EN ISO 13485:2016/A11:2021
EN ISO 13485:2016/A11:2021
Requirements of Article 10 Clause(s) / sub-clause(s) of
Remarks / Notes
of Regulation (EU) 2017/745 this EN
within the quality management system.
The detail in Article 83 is not specified
explicitly.
rd
9 3 paragraph (j) 7.2.3 Partially covered. EN ISO 13485 specifies
requirements for communication with
customers and regulatory authorities.
The term ‘regulatory authorities’ is used
in a general context and the terms
competent authority and notified body,
as used in the Regulation, are not
explicitly mentioned. Other economic
operators and other stakeholders are not
explicitly mentioned.
rd
9, 3 paragraph (k) 8.2.2, 8.2.3, 8.3.3 Partially covered. EN ISO 13485 requires
processes for reporting events in
accordance with applicable regulatory
requirements. The details of the
vigilance system and the timescales for
reporting are not specified explicitly.
rd
9, 3 paragraph (l) 8.5.2, 8.5.3 Covered. EN ISO 13485 specifies
requirements for management of
corrective actions and preventive
actions, including verification of their
effectiveness.
rd
9, 3 paragraph (m) 8.2.5, 8.2.6, 8.4, 8.5 Covered. EN ISO 13485 includes
requirements on monitoring and
measurement of processes, analysis of
data and improvement of product.
10 8.2.1, 8.5.1 Partially covered. EN ISO 13485 requires
a system of post market surveillance in
accordance with regulatory
requirements within the quality
management system. The detail in
Article 83 is not covered explicitly.
11 4.2.3a), 7.3.3, 7.5.1e) Partially covered. EN ISO 13485 includes
a general requirement for design inputs
to include applicable regulatory
requirements and for the medical device
file to include the labelling, including
instructions for use. Specific
requirements of Chapter III of Annex I
are not explicitly included nor is the
language in which the information is to
be provided. The physical characteristics
of the information on the label are not
covered explicitly.
12 7.2.3, 8.2.2d), 8.2.3, 8.3.3 Partially covered. EN ISO 13485 uses the
definitions in ISO 9000 where this
situation would be within the definition
of a correction rather than a corrective
action. Communication with customers
and regulatory authorities is required.
8
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SIST EN ISO 13485:2016/A11:2021
EN ISO 13485:2016/A11:2021
Requirements of Article 10 Clause(s) / sub-clause(s) of
Remarks / Notes
of Regulation (EU) 2017/745 this EN
The term ‘regulatory authorities’ is used
in a general context and the terms
competent authority and notified body,
as used in the Regulation, are not
explicitly mentioned. Distributors as a
specific category of customer, and
importers and authorized representative
are not explicitly mentioned.
13 8.2.3 Partially covered. EN ISO 13485 includes
the requirements on adverse event
reporting and mentions actions in the
field to be reported. The detailed
requirements in Articles 87 and 88 are
not specified explicitly.
st
14, 1 paragraph 7.2.3 Partially covered. EN ISO 13485 requires
communication with regulatory
authorities in accordance with
applicable regulatory requirements. The
term ‘regulatory authorities’ is used in a
general context and the term competent
authority, as used in the Regulation, is
not explicitly mentioned. The provision
of information as in the Regulation, the
language in which it is to be provided,
the provision of samples of the device
free of charge or granting access to the
device are not covered explicitly.
nd rd th
14, 2 , 3 and 4 paragraphs Not covered. Refers to actions of the
competent authority outside the scope of
the standard.
15 4.1, 4.2.3, 7.2.3, 7.4 Partially covered. EN ISO 13485 requires
communication with regulatory
authorities in accordance with
applicable regulatory requirements. The
provision of information on the identity
of a third party that designed or
manufactured the medical device as in
the Regulation are not covered explicitly.
16 Not covered.
9
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SIST EN ISO 13485:2016/A11:2021
EN ISO 13485:2016/A11:2021
Table ZA.2 – Correspondence between this European standard and the requirements of Annex IX of
Regulation (EU) 2017/745 [OJ L 117]
Requirements of Annex IX of Clause(s) / sub-clause(s) of
Remarks / Notes
Regulation (EU) 2017/745 this EN
1 4.1 Partially covered. EN ISO 13485 requires
the quality management system to
comply with applicable regulatory
requirements. EN ISO 13485 is
applicable to all sizes of organization and
all types and class of medical device.
EN ISO 13485 does not have
requirements for the quality
management system to be subject to
third party assessment or certification.
st
2.1, 1 sentence Not covered.
2.1, bullet 1 Not covered.
2.1, bullet 2 4.2 Covered. EN ISO 13485 requires that the
quality management system
documentation includes information on
the device(s) within its scope.
2.1, bullet 3 Not covered.
2.1, bullet 4 Not covered.
2.1, bullet 5 4.2 Covered. EN ISO 13485 specifies the
quality management system
documentation and how it is controlled.
2.1, bullet 6 4.2, 5.1 Partially covered. EN ISO 13485 requires
evidence of top management
commitment to implementing the quality
management system. EN ISO 13485 does
not explicitly require a documented
undertaking.
2.1, bullet 7 4.1.4, 4.2, 5.1, 5.4.2, 5.6, 6.1, 8 Covered. EN ISO 13485 requires that the
quality management system is applied
and maintained.
2.1, bullet 8 8.2.1, 8.5.1 Partially covered. EN ISO 13485
references inclusion of applicable
regulatory requirements on post market
surveillance into the quality
management system. The detailed
requirements in the Regulation and to
post-market clinical follow-up are not
referenced explicitly.
2.1, bullet 9 8.2.1, 8.5.1 Partially covered. EN ISO 13485
references inclusion of applicable
regulatory requirements on post market
surveillance into the quality
management system. The detailed
requirements in the regulation and post-
market clinical follow-up are not
referenced explicitly.
10
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SIST EN ISO 13485:2016/A11:2021
EN ISO 13485:2016/A11:2021
Requirements of Annex IX of Clause(s) / sub-clause(s) of
Remarks / Notes
Regulation (EU) 2017/745 this EN
2.1, bullet 10 Not covered. EN ISO 13485 requires
clinical evaluation in accordance with
planned and documented arrangements
and applicable regulatory requirements.
A clinical evaluation plan is not
referenced explicitly.
2.1, bullet 11 Not covered.
st
2.2, 1 paragraph 4.1, 4.2, 5, 6, 8 Partially covered. EN ISO 13485 requires
that the quality management system is
implemented systematically in
accordance with the requirements of the
standard and applicable regulatory
requirements. EN ISO 13485 requires a
quality manual, written policies and
procedures, quality planning and quality
records.
nd
2.2, 2 paragraph (a) 4.2.1a), 5.1c), 5.3c), 5.4.1, 7.1a) Covered. EN ISO 13485 requires that
quality objectives are defined and
documented.
nd
2.2, 2 paragraph (b) indent 1 5.5.1 Covered. EN ISO 13485 requires that
organizational structures, roles and
responsibilities, and interrelationships
are defined and documented.
nd
2.2, 2 paragraph (b) indent 2 5.6, 7.3.5, 8.1, 8.2.1, 8.2.4, 8.2.5, Covered. EN ISO 13485 includes
8.2.6, 8.3, 8.4, requirements on monitoring the
operation of the quality management
system and the control of non-
conforming product.
nd
2.2 2 paragraph (b) indent 3 4.1.5, 7.4.1 Covered. EN ISO 13485 has
requirements for cases when an
organization outsources an activity, and
these requirements link with the
requirements for evaluation and
selection of suppliers, their monitoring
and their re-evaluation.
nd
2.2 2 paragraph (b) indent 4 Not covered.
nd
2.2, 2 paragraph (c) 4.2.5, 7.3, Covered. EN ISO 13485 covers design
and development controls as well as the
control of documentation, including
records.
nd
2.2, 2 paragraph (c) indent 1 4.1.1, 7.3.9 Partially covered. EN ISO 13485 requires
that the organization identifies
applicable regulatory requirements and
incorporates them in its quality
management system. An explicit
requirement for a documented
regulatory strategy is not included.
Control of design and development
changes is explicitly specified.
11
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SIST EN ISO 13485:2016/A11:2021
EN ISO 13485:2016/A11:2021
Requirements of Annex IX of Clause(s) / sub-clause(s) of
Remarks / Notes
Regulation (EU) 2017/745 this EN
nd
2.2, 2 paragraph (c) indent 2 7.2.1c), 7.3.3 Partially covered. EN ISO 13485 includes
a general reference to inclusion of
applicable regulatory requirements and
standards as a design input. The general
safety and performance requirements,
harmonized standards or common
specifications are not mentioned
explicitly.
nd
2.2, 2 paragraph (c) indent 3 4.1.2, 7.1 Partially covered. EN ISO 13485 includes
requirements to apply a risk-based
approach to the quality management
system and apply risk management in
product realization. The detail of the
specific requirements of Annex 1 of the
Regulation are not detailed specifically.
nd
2.2, 2 paragraph (c) indent 4 Not covered. EN ISO 13485 requires
clinical evaluation in accordance with
applicable regulatory requirements. The
specific details in Article 61 and
Annex XIV and reference to post market
clinical follow-up (PMCF) are not
included explicitly.
nd
2.2, 2 paragraph (c) indent 5 7.3 Partially covered. EN ISO 13485 details
requirements for design and
development verification and validation.
Preclinical evaluation as an aspect of
design verification is not mentioned
explicitly.
nd
2.2, 2 paragraph (c) indent 6 4.2.3a), 7.3.3b), 7.5.1e) Partially covered. EN ISO 13485 includes
a general requirement for design inputs
to include applicable regulatory
requirements and for the medical device
file to include the labelling, including
instructions for use. Specific
requirements of Chapter III of Annex I
are not included explicitly.
nd
2.2, 2 paragraph (c) indent 7 7.5.8, 7.5.9 Covered. EN ISO 13485 specifies
requirements for identification and
traceability.
nd
2.2, 2 paragraph (c) indent 8 4.1.4, 4.2.4, 5.6.2, 5.6.3, 7.3.3, Partially covered. EN ISO 13485 includes
7.3.9 general reference to regulatory
requirements and standards as design
and development inputs. Identification
of new or revised regulatory
requirements is identified as an input
into Management Review and changes
needed as a result of such inputs are
required as outputs of Management
Review. Change to the medical device is
covered through control of design and
development changes.
12
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SIST EN ISO 13485:2016/A11:2021
EN ISO 13485:2016/A11:2021
Requirements of Annex IX of Clause(s) / sub-clause(s) of
Remarks / Notes
Regulation (EU) 2017/745 this EN
nd
2.2, 2 paragraph (d). 7.5.1, 7.5.5, 7.5.6, 7.5.7 Covered. EN ISO 13485 covers controls
in product realization including
sterilization.
nd
2.2, 2 paragraph (e). 7.4.3, 7.5.1, 7.5.9, 7.6, 8.2.5, Covered. EN ISO 13485 covers
8.2.6 monitoring and measurement of product
and the calibration of test equipment.
rd
2.2 3 paragraph 7.2.3, Partially covered. EN ISO 13485 requires
communication with regulatory
authorities in accordance with
applicable regulatory requirements. The
term ‘regulatory authorities’ is used in a
general context and the term notified
body, as used in the Regulation, is not
explicitly mentioned. The provision of
specific information as detailed in the
Regulation is not detailed explicitly.
2.4 4.1.4, 7.2.3 Partially covered. EN ISO 13485 requires
incorporation of regulatory
requirements into the QMS and
communication with regulatory
authorities in accordance with
regulatory requirements. The term
‘regulatory authorities’ is used in a
general context and the term notified
body, as used in the Regulation, is not
explicitly mentioned. Communication in
relation to changes in the QMS or range
of medical devices is not referred to
specifically.
3.2 7.2.3 Partially covered. EN ISO 13485 requires
communication with regulatory
authorities in accordance with
applicable regulatory requirements. The
term ‘r
...
SLOVENSKI STANDARD
SIST EN ISO 13485:2016/A11:2021
01-december-2021
Medicinski pripomočki - Sistemi vodenja kakovosti - Zahteve za zakonodajne
namene - Dopolnilo A1 (ISO 13485:2016)
Medical devices - Quality management systems - Requirements for regulatory purposes
(ISO 13485:2016)
Medizinprodukte - Qualitätsmanagementsysteme - Anforderungen für regulatorische
Zwecke (ISO 13485:2016)
Dispositifs médicaux - Systèmes de management de la qualité - Exigences à des fins
réglementaires (ISO 13485:2016)
Ta slovenski standard je istoveten z: EN ISO 13485:2016/A11:2021
ICS:
03.100.70 Sistemi vodenja Management systems
11.020.01 Vodenje kakovosti in Quality and environmental
ravnanje z okoljem v management in health care
zdravstvu
SIST EN ISO 13485:2016/A11:2021 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 13485:2016/A11:2021
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SIST EN ISO 13485:2016/A11:2021
EUROPEAN STANDARD
EN ISO 13485:2016/A11
NORME EUROPÉENNE
EUROPÄISCHE NORM
September 2021
ICS 03.100.70; 11.040.01
English version
Medical devices - Quality management systems -
Requirements for regulatory purposes (ISO 13485:2016)
Dispositifs médicaux - Systèmes de management de la Medizinprodukte - Qualitätsmanagementsysteme -
qualité - Exigences à des fins réglementaires (ISO Anforderungen für regulatorische Zwecke (ISO
13485:2016) 13485:2016)
This amendment A11 modifies the European Standard EN ISO 13485:2016; it was approved by CEN on 12 April 2021.
CEN and CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for
inclusion of this amendment into the relevant national standard without any alteration. Up-to-date lists and bibliographical
references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to
any CEN and CENELEC member.
This amendment exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN and CENELEC member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.
CEN and CENELEC members are the national standards bodies and national electrotechnical committees of Austria, Belgium,
Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy,
Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia,
Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.
CEN-CENELEC Management Centre:
Rue de la Science 23, B-1040 Brussels
© 2021 CEN/CENELEC All rights of exploitation in any form and by any means Ref. No. EN ISO 13485:2016/A11:2021 E
reserved worldwide for CEN national Members and for
CENELEC Members.
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SIST EN ISO 13485:2016/A11:2021
EN ISO 13485:2016/A11:2021
Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European standard and the
requirements of Regulation (EU) 2017/745 aimed to be covered . 4
Annex ZB (informative) Relationship between this European standard and the
requirements of Regulation (EU) 2017/746 aimed to be covered . 16
2
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SIST EN ISO 13485:2016/A11:2021
EN ISO 13485:2016/A11:2021
European foreword
This document (EN ISO 13485:2016/A11:2021) has been prepared by Technical Committee
CEN/CLC/TC 3 “Quality management and corresponding general aspects for medical devices” the
secretariat of which is held by NEN.
This document amends EN ISO 13485:2016, incorporating corrigenda March 2016, December 2016 and
2018, with a revised European Foreword and European Annexes ZA and ZB.
This Amendment to the European Standard EN ISO 13485:2016 has been prepared under a mandate
given to CEN by the European Commission and the European Free Trade Association, and supports
requirements of EU Regulation(s).
For relationship with EU Regulation(s), see informative Annex ZA, and ZB, which are an integral part of
this document.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN websites.
The following referenced documents are indispensable for the application of this document. For undated
references, the edition of the referenced document (including any amendments) listed below applies. For
dated references, only the edition cited applies. However, for any use of this standard within the meaning
of Annex ZA or ZB, the user should always check that any referenced document has not been superseded
and that its relevant contents can still be considered the generally acknowledged state-of-art.
When an IEC or ISO standard is referred to in the ISO standard text, this should be understood as a
normative reference to the corresponding EN standard, if available, and otherwise to the dated version
of the ISO or IEC standard as listed below.
NOTE The way in which these referenced documents are cited in normative requirements determines the
extent (in whole or in part) to which they apply.
Table – Correlation between normative references and dated EN and ISO standards
Normative references Equivalent dated standard
as listed in Clause 2 of the ISO
EN ISO
standard
ISO 9000:2015 EN ISO 9000:2015 ISO 9000:2015
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia,
Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland,
Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of North
Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United
Kingdom.
3
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SIST EN ISO 13485:2016/A11:2021
EN ISO 13485:2016/A11:2021
Annex ZA
(informative)
Relationship between this European standard and the requirements of
Regulation (EU) 2017/745 aimed to be covered
This European standard has been prepared under a Commission’s standardisation request M/575 of
14.4.2021 to provide one voluntary means of conforming to the requirements of Regulation (EU)
2017/745 of 5 April 2017 concerning medical devices [OJ L 117].
Once this standard is cited in the Official Journal of the European Union under that Regulation, compliance
with the normative clauses of this standard given in Tables ZA.1, ZA.2 or ZA.3 confers, within the limits
of the scope of this standard, a presumption of conformity with the corresponding requirements of that
Regulation, and associated EFTA regulations.
This Annex covers the relationship of this European standard with:
• the general obligations of the manufacturer in Article 10 (Table ZA.1); and,
• the quality management system requirements in the conformity assessment annexes (Annexes IX
and XI) (Table ZA.2 and ZA.3 respectively).
EN ISO 13485:2016 is an adoption of an international standard, ISO 13485:2016, which is intended to be
applicable in jurisdictions all over the world. Therefore, it is not the primary goal of ISO 13485:2016 to
cover exactly the European quality management system requirements. Consequently, for all of the quality
management system requirements, conformity is not entirely achieved by complying only with the
requirements specified in EN ISO 13485. Manufacturers and conformity assessment bodies will need to
integrate the quality management system requirements in the applicable European Regulation into the
processes provided by EN ISO 13485. In addition, the European Regulations require the incorporation of
certain processes in the quality management system, such as clinical evaluation, risk management, post-
market surveillance, and assignment of unique device identification. EN ISO 13485 requires the
integration of these processes into the quality management system in accordance with regulatory
requirements but does not explicitly include the details of the particular European Union regulatory
requirements within the standard. Furthermore, the definitions in applicable regulatory requirements
differ from nation to nation and region to region. As a result, the definitions in this document can differ
in wording from those in European Regulations. For use in support of European requirements, definitions
in the European regulations for medical devices take precedence.
In addition to requirements on the manufacturer’s quality management system, Article 10 and
Annexes IX and XI of the European Regulations include a description of the regulatory processes and
activities undertaken by the notified body, competent authority and European Commission, which are
outside of the scope of EN ISO 13485 and therefore not covered by the standard.
NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk
management process needs to be in compliance with Regulation (EU) 2017/745. This means that risks have to be
‘reduced as far as possible’, ‘reduced to the lowest possible level’, ‘reduced as far as possible and appropriate’,
‘removed or reduced as far as possible’, ‘eliminated or reduced as far as possible’, ’removed or minimized as far as
possible’, or ‘minimized’, according to the wording of the corresponding General Safety and Performance
Requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with General Safety
and Performance Requirements 1, 2, 3, 4, 5, 8, 9, 10, 11, 14, 16, 17, 18, 19, 20, 21 and 22 of the Regulation.
4
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SIST EN ISO 13485:2016/A11:2021
EN ISO 13485:2016/A11:2021
NOTE 3 This Annex ZA is based on normative references according to the table of references in the European
Foreword, replacing the references in the core text.
NOTE 4 When a requirement does not appear in Tables ZA.1, ZA.2 or ZA.3 it means that it is not addressed by
this European Standard.
Table ZA.1 – Correspondence between this European standard and the requirements of Article 10 of
Regulation (EU) 2017/745 [OJ L 117]
Requirements of Article 10 Clause(s) / sub-clause(s) of
Remarks / Notes
of Regulation (EU) 2017/745 this EN
1 4.1, 7.1, 7.2.1 c), 7.2.2 c), 7.3, 7.5 Partially covered. EN ISO 13485 includes
requirements for the QMS, design and
development and manufacturing that
require incorporation of the regulatory
requirements into the quality
management system.
2 7.1 Partially covered. EN ISO 13485 includes
requirements to risk management in
product realization. The detail of the
specific requirements of Annex 1,
Chapter 1 of the Regulation is not stated
explicitly.
3 Not covered. 7.3.7 of EN ISO 13485
requires clinical evaluation in
accordance with applicable regulatory
requirements. The details contained in
Article 61 or Annex XIV are not provided.
st
4, 1 paragraph 4.2.3 Partially covered. EN ISO 13485 requires
that the quality management system
includes one or more files either
containing or referencing documents
generated to demonstrate compliance
with applicable regulatory requirements.
A summary of the types of documents is
provided. All the detail in Annexes II and
III is not provided explicitly.
nd
4, 2 paragraph Not covered. Refers to action by the
European Commission outside the scope
of the standard.
5 4.2.3 Partially covered. EN ISO 13485 requires
that the quality management system
includes one or more files either
containing or referencing documents
generated to demonstrate compliance
with applicable regulatory requirements.
A summary of the types of documents is
provided. All the detail in Annex XIII is
not provided explicitly.
6 Not covered. Preparation of the EU
declaration of conformity is not covered
in EN ISO 13485
7 Not covered. 7.5.8 of EN ISO 13485
includes a requirement to control the
5
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SIST EN ISO 13485:2016/A11:2021
EN ISO 13485:2016/A11:2021
Requirements of Article 10 Clause(s) / sub-clause(s) of
Remarks / Notes
of Regulation (EU) 2017/745 this EN
UDI under the quality management
system. The detail of the system
prescribed in Article 27, and with the
registration obligations referred to in
Articles 29 and 31, are not provided.
st
8, 1 paragraph 4.2.4, 4.2.5, 7.2.3 Partially covered. EN ISO 13485 requires
the retention of documents, including
records, for at least the period specified
by applicable regulatory requirements.
The retention time defined in the
Regulations is not provided explicitly.
nd
8, 2 paragraph 7.2.3 Partially covered. EN ISO 13485 requires
communication with regulatory
authorities in accordance with
applicable regulatory requirements. The
term ‘regulatory authorities’ is used in a
general context and the term competent
authority, as used in the Regulation, is
not explicitly mentioned. The provision
of specific information as detailed in the
Regulation is not stated explicitly.
rd
8, 3 paragraph Not covered.
st st
9, 1 paragraph, 1 sentence 4, 5, 6, 7, 8 Covered. EN ISO 13485 requires the
quality management system to comply
with applicable regulatory requirements
and that production is planned, carried
out, monitored and controlled to ensure
that product conforms to specification
and regulatory requirements.
st nd
9, 1 paragraph, 2 sentence 4.1.4, 4.2.4, 5.6.2, 5.6.3, 7.3.3, Partially covered. EN ISO 13485 includes
7.3.9 general reference to regulatory
requirements and standards as design
and development inputs. Identification
of new or revised regulatory
requirements is identified as an input
into Management Review) and changes
needed as a result of such changes
required as outputs of Management
Review). Change to the medical device is
covered through control of design and
development changes. Common
specifications are not explicitly
mentioned.
rd
9, 1st paragraph, 3 sentence 4.1 Partially covered. EN ISO 13485 requires
that the effectiveness of the quality
management system is maintained and
provides requirements for improvement
processes, including corrective action
and preventive action. There is no
explicit requirement for the quality
management system to be continually
improved.
6
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SIST EN ISO 13485:2016/A11:2021
EN ISO 13485:2016/A11:2021
Requirements of Article 10 Clause(s) / sub-clause(s) of
Remarks / Notes
of Regulation (EU) 2017/745 this EN
nd
9, 2 paragraph 4, 5, 6, 7, 8 Covered.
rd
9, 3 paragraph (a) 4.1.1, 7.3.9 Partially covered. EN ISO 13485 requires
that the organization identifies
applicable regulatory requirements and
incorporates them in its quality
management system. An explicit
requirement for a documented
regulatory strategy is not included.
Control of design and development
changes is explicitly specified.
rd
9, 3 paragraph (b) 4.2.3, 7.2.1c), 7.3.3b), 7.3.4a), Partially covered. EN ISO 13485 includes
7.3.5 a general reference to inclusion of
applicable regulatory requirements and
standards as a design input. The general
safety and performance requirements,
harmonized standards or common
specifications are not mentioned
explicitly.
rd
9, 3 paragraph (c) 5 Covered. EN ISO 13485 defines
responsibilities of top management.
rd
9, 3 paragraph (d) 4.1.5, 6, 7.4.1 Covered. EN ISO 13485 includes specific
requirements for provision of human
resources including competence,
infrastructure, work environment and
contamination control.
rd
9, 3 paragraph (e) 4.1.2, 7.1 Partially covered. EN ISO 13485 includes
requirements to apply a risk-based
approach to the quality management
system and apply risk management in
product realization. The detail of the
specific requirements of Annex 1 of the
Regulation are not detailed specifically.
rd
9,3 paragraph (f) Not covered. EN ISO 13485 requires
clinical evaluation in accordance with
applicable regulatory requirements. The
specific details in Article 61 and
Annex XIV and reference to post market
clinical follow-up (PMCF) are not
included explicitly.
rd
9, 3 paragraph (g) 7.1, 7.3.2, 7.3.8, 7.5.1, 7.5.4 Covered. EN ISO 13485 requires
planning of product realization, planning
of design and development and planning
of production and service provision.
rd
9, 3 paragraph (h) Not covered. EN ISO 13485 includes a
requirement to control the UDI under
the quality management system. The
detail of the system prescribed in the
Regulation is not specified explicitly.
rd
9, 3 paragraph (i) 8.2.1, 8.5.1 Partially covered. EN ISO 13485 requires
a system of post market surveillance
7
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SIST EN ISO 13485:2016/A11:2021
EN ISO 13485:2016/A11:2021
Requirements of Article 10 Clause(s) / sub-clause(s) of
Remarks / Notes
of Regulation (EU) 2017/745 this EN
within the quality management system.
The detail in Article 83 is not specified
explicitly.
rd
9 3 paragraph (j) 7.2.3 Partially covered. EN ISO 13485 specifies
requirements for communication with
customers and regulatory authorities.
The term ‘regulatory authorities’ is used
in a general context and the terms
competent authority and notified body,
as used in the Regulation, are not
explicitly mentioned. Other economic
operators and other stakeholders are not
explicitly mentioned.
rd
9, 3 paragraph (k) 8.2.2, 8.2.3, 8.3.3 Partially covered. EN ISO 13485 requires
processes for reporting events in
accordance with applicable regulatory
requirements. The details of the
vigilance system and the timescales for
reporting are not specified explicitly.
rd
9, 3 paragraph (l) 8.5.2, 8.5.3 Covered. EN ISO 13485 specifies
requirements for management of
corrective actions and preventive
actions, including verification of their
effectiveness.
rd
9, 3 paragraph (m) 8.2.5, 8.2.6, 8.4, 8.5 Covered. EN ISO 13485 includes
requirements on monitoring and
measurement of processes, analysis of
data and improvement of product.
10 8.2.1, 8.5.1 Partially covered. EN ISO 13485 requires
a system of post market surveillance in
accordance with regulatory
requirements within the quality
management system. The detail in
Article 83 is not covered explicitly.
11 4.2.3a), 7.3.3, 7.5.1e) Partially covered. EN ISO 13485 includes
a general requirement for design inputs
to include applicable regulatory
requirements and for the medical device
file to include the labelling, including
instructions for use. Specific
requirements of Chapter III of Annex I
are not explicitly included nor is the
language in which the information is to
be provided. The physical characteristics
of the information on the label are not
covered explicitly.
12 7.2.3, 8.2.2d), 8.2.3, 8.3.3 Partially covered. EN ISO 13485 uses the
definitions in ISO 9000 where this
situation would be within the definition
of a correction rather than a corrective
action. Communication with customers
and regulatory authorities is required.
8
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SIST EN ISO 13485:2016/A11:2021
EN ISO 13485:2016/A11:2021
Requirements of Article 10 Clause(s) / sub-clause(s) of
Remarks / Notes
of Regulation (EU) 2017/745 this EN
The term ‘regulatory authorities’ is used
in a general context and the terms
competent authority and notified body,
as used in the Regulation, are not
explicitly mentioned. Distributors as a
specific category of customer, and
importers and authorized representative
are not explicitly mentioned.
13 8.2.3 Partially covered. EN ISO 13485 includes
the requirements on adverse event
reporting and mentions actions in the
field to be reported. The detailed
requirements in Articles 87 and 88 are
not specified explicitly.
st
14, 1 paragraph 7.2.3 Partially covered. EN ISO 13485 requires
communication with regulatory
authorities in accordance with
applicable regulatory requirements. The
term ‘regulatory authorities’ is used in a
general context and the term competent
authority, as used in the Regulation, is
not explicitly mentioned. The provision
of information as in the Regulation, the
language in which it is to be provided,
the provision of samples of the device
free of charge or granting access to the
device are not covered explicitly.
nd rd th
14, 2 , 3 and 4 paragraphs Not covered. Refers to actions of the
competent authority outside the scope of
the standard.
15 4.1, 4.2.3, 7.2.3, 7.4 Partially covered. EN ISO 13485 requires
communication with regulatory
authorities in accordance with
applicable regulatory requirements. The
provision of information on the identity
of a third party that designed or
manufactured the medical device as in
the Regulation are not covered explicitly.
16 Not covered.
9
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SIST EN ISO 13485:2016/A11:2021
EN ISO 13485:2016/A11:2021
Table ZA.2 – Correspondence between this European standard and the requirements of Annex IX of
Regulation (EU) 2017/745 [OJ L 117]
Requirements of Annex IX of Clause(s) / sub-clause(s) of
Remarks / Notes
Regulation (EU) 2017/745 this EN
1 4.1 Partially covered. EN ISO 13485 requires
the quality management system to
comply with applicable regulatory
requirements. EN ISO 13485 is
applicable to all sizes of organization and
all types and class of medical device.
EN ISO 13485 does not have
requirements for the quality
management system to be subject to
third party assessment or certification.
st
2.1, 1 sentence Not covered.
2.1, bullet 1 Not covered.
2.1, bullet 2 4.2 Covered. EN ISO 13485 requires that the
quality management system
documentation includes information on
the device(s) within its scope.
2.1, bullet 3 Not covered.
2.1, bullet 4 Not covered.
2.1, bullet 5 4.2 Covered. EN ISO 13485 specifies the
quality management system
documentation and how it is controlled.
2.1, bullet 6 4.2, 5.1 Partially covered. EN ISO 13485 requires
evidence of top management
commitment to implementing the quality
management system. EN ISO 13485 does
not explicitly require a documented
undertaking.
2.1, bullet 7 4.1.4, 4.2, 5.1, 5.4.2, 5.6, 6.1, 8 Covered. EN ISO 13485 requires that the
quality management system is applied
and maintained.
2.1, bullet 8 8.2.1, 8.5.1 Partially covered. EN ISO 13485
references inclusion of applicable
regulatory requirements on post market
surveillance into the quality
management system. The detailed
requirements in the Regulation and to
post-market clinical follow-up are not
referenced explicitly.
2.1, bullet 9 8.2.1, 8.5.1 Partially covered. EN ISO 13485
references inclusion of applicable
regulatory requirements on post market
surveillance into the quality
management system. The detailed
requirements in the regulation and post-
market clinical follow-up are not
referenced explicitly.
10
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SIST EN ISO 13485:2016/A11:2021
EN ISO 13485:2016/A11:2021
Requirements of Annex IX of Clause(s) / sub-clause(s) of
Remarks / Notes
Regulation (EU) 2017/745 this EN
2.1, bullet 10 Not covered. EN ISO 13485 requires
clinical evaluation in accordance with
planned and documented arrangements
and applicable regulatory requirements.
A clinical evaluation plan is not
referenced explicitly.
2.1, bullet 11 Not covered.
st
2.2, 1 paragraph 4.1, 4.2, 5, 6, 8 Partially covered. EN ISO 13485 requires
that the quality management system is
implemented systematically in
accordance with the requirements of the
standard and applicable regulatory
requirements. EN ISO 13485 requires a
quality manual, written policies and
procedures, quality planning and quality
records.
nd
2.2, 2 paragraph (a) 4.2.1a), 5.1c), 5.3c), 5.4.1, 7.1a) Covered. EN ISO 13485 requires that
quality objectives are defined and
documented.
nd
2.2, 2 paragraph (b) indent 1 5.5.1 Covered. EN ISO 13485 requires that
organizational structures, roles and
responsibilities, and interrelationships
are defined and documented.
nd
2.2, 2 paragraph (b) indent 2 5.6, 7.3.5, 8.1, 8.2.1, 8.2.4, 8.2.5, Covered. EN ISO 13485 includes
8.2.6, 8.3, 8.4, requirements on monitoring the
operation of the quality management
system and the control of non-
conforming product.
nd
2.2 2 paragraph (b) indent 3 4.1.5, 7.4.1 Covered. EN ISO 13485 has
requirements for cases when an
organization outsources an activity, and
these requirements link with the
requirements for evaluation and
selection of suppliers, their monitoring
and their re-evaluation.
nd
2.2 2 paragraph (b) indent 4 Not covered.
nd
2.2, 2 paragraph (c) 4.2.5, 7.3, Covered. EN ISO 13485 covers design
and development controls as well as the
control of documentation, including
records.
nd
2.2, 2 paragraph (c) indent 1 4.1.1, 7.3.9 Partially covered. EN ISO 13485 requires
that the organization identifies
applicable regulatory requirements and
incorporates them in its quality
management system. An explicit
requirement for a documented
regulatory strategy is not included.
Control of design and development
changes is explicitly specified.
11
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SIST EN ISO 13485:2016/A11:2021
EN ISO 13485:2016/A11:2021
Requirements of Annex IX of Clause(s) / sub-clause(s) of
Remarks / Notes
Regulation (EU) 2017/745 this EN
nd
2.2, 2 paragraph (c) indent 2 7.2.1c), 7.3.3 Partially covered. EN ISO 13485 includes
a general reference to inclusion of
applicable regulatory requirements and
standards as a design input. The general
safety and performance requirements,
harmonized standards or common
specifications are not mentioned
explicitly.
nd
2.2, 2 paragraph (c) indent 3 4.1.2, 7.1 Partially covered. EN ISO 13485 includes
requirements to apply a risk-based
approach to the quality management
system and apply risk management in
product realization. The detail of the
specific requirements of Annex 1 of the
Regulation are not detailed specifically.
nd
2.2, 2 paragraph (c) indent 4 Not covered. EN ISO 13485 requires
clinical evaluation in accordance with
applicable regulatory requirements. The
specific details in Article 61 and
Annex XIV and reference to post market
clinical follow-up (PMCF) are not
included explicitly.
nd
2.2, 2 paragraph (c) indent 5 7.3 Partially covered. EN ISO 13485 details
requirements for design and
development verification and validation.
Preclinical evaluation as an aspect of
design verification is not mentioned
explicitly.
nd
2.2, 2 paragraph (c) indent 6 4.2.3a), 7.3.3b), 7.5.1e) Partially covered. EN ISO 13485 includes
a general requirement for design inputs
to include applicable regulatory
requirements and for the medical device
file to include the labelling, including
instructions for use. Specific
requirements of Chapter III of Annex I
are not included explicitly.
nd
2.2, 2 paragraph (c) indent 7 7.5.8, 7.5.9 Covered. EN ISO 13485 specifies
requirements for identification and
traceability.
nd
2.2, 2 paragraph (c) indent 8 4.1.4, 4.2.4, 5.6.2, 5.6.3, 7.3.3, Partially covered. EN ISO 13485 includes
7.3.9 general reference to regulatory
requirements and standards as design
and development inputs. Identification
of new or revised regulatory
requirements is identified as an input
into Management Review and changes
needed as a result of such inputs are
required as outputs of Management
Review. Change to the medical device is
covered through control of design and
development changes.
12
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SIST EN ISO 13485:2016/A11:2021
EN ISO 13485:2016/A11:2021
Requirements of Annex IX of Clause(s) / sub-clause(s) of
Remarks / Notes
Regulation (EU) 2017/745 this EN
nd
2.2, 2 paragraph (d). 7.5.1, 7.5.5, 7.5.6, 7.5.7 Covered. EN ISO 13485 covers controls
in product realization including
sterilization.
nd
2.2, 2 paragraph (e). 7.4.3, 7.5.1, 7.5.9, 7.6, 8.2.5, Covered. EN ISO 13485 covers
8.2.6 monitoring and measurement of product
and the calibration of test equipment.
rd
2.2 3 paragraph 7.2.3, Partially covered. EN ISO 13485 requires
communication with regulatory
authorities in accordance with
applicable regulatory requirements. The
term ‘regulatory authorities’ is used in a
general context and the term notified
body, as used in the Regulation, is not
explicitly mentioned. The provision of
specific information as detailed in the
Regulation is not detailed explicitly.
2.4 4.1.4, 7.2.3 Partially covered. EN ISO 13485 requires
incorporation of regulatory
requirements into the QMS and
communication with regulatory
authorities in accordance with
regulatory requirements. The term
‘regulatory authorities’ is used in a
general context and the term notified
body, as used in the Regulation, is not
explicitly mentioned. Communication in
relation to changes in the QMS or range
of medical devices is not referred to
specifically.
3.2 7.2.3 Partially covered. EN ISO 13485 requires
communication with regulatory
authorities in accordance with
applicable regulatory requirements. The
term ‘re
...
SLOVENSKI STANDARD
SIST EN ISO 13485:2016/oprA1:2019
01-december-2019
Medicinski pripomočki - Sistemi vodenja kakovosti - Zahteve za zakonodajne
namene (ISO 13485:2016)
Medical devices - Quality management systems - Requirements for regulatory purposes
(ISO 13485:2016)
Medizinprodukte - Qualitätsmanagementsysteme - Anforderungen für regulatorische
Zwecke (ISO 13485:2016)
Dispositifs médicaux - Systèmes de management de la qualité - Exigences à des fins
réglementaires (ISO 13485:2016)
Ta slovenski standard je istoveten z: EN ISO 13485:2016/prA1
ICS:
03.100.70 Sistemi vodenja Management systems
11.020.01 Vodenje kakovosti in Quality and environmental
ravnanje z okoljem v management in health care
zdravstvu
SIST EN ISO 13485:2016/oprA1:2019 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 13485:2016/oprA1:2019
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SIST EN ISO 13485:2016/oprA1:2019
EUROPEAN STANDARD
DRAFT
EN ISO 13485:2016
NORME EUROPÉENNE
EUROPÄISCHE NORM
prA1
October 2019
ICS 03.100.70; 11.040.01
English version
Medical devices - Quality management systems -
Requirements for regulatory purposes (ISO 13485:2016)
Dispositifs médicaux - Systèmes de management de la Medizinprodukte - Qualitätsmanagementsysteme -
qualité - Exigences à des fins réglementaires (ISO Anforderungen für regulatorische Zwecke (ISO
13485:2016) 13485:2016)
This draft amendment is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee
CEN/CLC/JTC 3.
This draft amendment A1, if approved, will modify the European Standard EN ISO 13485:2016. If this draft becomes an
amendment, CEN and CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the
conditions for inclusion of this amendment into the relevant national standard without any alteration.
This draft amendment was established by CEN and CENELEC in three official versions (English, French, German). A version in
any other language made by translation under the responsibility of a CEN and CENELEC member into its own language and
notified to the CEN-CENELEC Management Centre has the same status as the official versions.
CEN and CENELEC members are the national standards bodies and national electrotechnical committees of Austria, Belgium,
Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy,
Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia,
Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.
Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are
aware and to provide supporting documentation.Recipients of this draft are invited to submit, with their comments, notification
of any relevant patent rights of which they are aware and to provide supporting documentation.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without
notice and shall not be referred to as a European Standard.
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SIST EN ISO 13485:2016/oprA1:2019
EN ISO 13485:2016/prA1:2019 (E)
Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European Standard and the conformity
assessment requirements of EU Directive 90/385/EEC on active implantable
medical devices [OJ L 189] (as amended) aimed to be covered . 4
Annex ZB (informative) Relationship between this European Standard and the conformity
assessment requirements of EU Directive 93/42/EEC on medical devices [OJ L 169]
(as amended) aimed to be covered . 9
Annex ZC (informative) Relationship between this European Standard and the conformity
assessment requirements of EU Directive 98/79/EC on in vitro diagnostic medical
devices [OJ L 331] aimed to be covered . 16
Annex ZD (informative) Relationship between this European standard and the
requirements of Regulation (EU) 2017/745 aimed to be covered . 24
Annex ZE (informative) Relationship between this European standard and the
requirements of Regulation (EU) 2017/746 aimed to be covered . 39
2
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SIST EN ISO 13485:2016/oprA1:2019
EN ISO 13485:2016/prA1:2019 (E)
European foreword
The text of ISO 13485:2016 has been prepared by Technical Committee ISO/TC 210 “Quality
management and corresponding general aspects for medical devices” of the International Organization
for Standardization (ISO) and has been taken over as EN ISO 13485:2016/prA1:2019 by Technical
Committee CEN/CLC/TC 3 “Quality management and corresponding general aspects for medical
devices” the secretariat of which is held by NEN.
This document is currently submitted to the CEN Enquiry.
This document supersedes EN ISO 13485:2016, incorporating corrigenda March 2016, December 2016
and 2018, with a revised European Foreword and European Annexes ZA, ZB and ZC, and additional
European Annexes ZD and ZE.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports requirements of EU Directive(s) and Regulation(s).
For relationship with EU Directive(s) and Regulation(s), see informative Annex ZA, ZB, ZC, ZD and ZE,
which are an integral part of this document.
The following referenced documents are indispensable for the application of this document. For undated
references, the edition of the referenced document (including any amendments) listed below applies. For
dated references, only the edition cited applies. However, for any use of this standard within the meaning
of Annex ZA, ZB, ZC, ZD or ZE, the user should always check that any referenced document has not been
superseded and that its relevant contents can still be considered the generally acknowledged state-of-art.
When an IEC or ISO standard is referred to in the ISO standard text, this should be understood as a
normative reference to the corresponding EN standard, if available, and otherwise to the dated version
of the ISO or IEC standard as listed below.
NOTE The way in which these referenced documents are cited in normative requirements determines the extent (in whole
or in part) to which they apply.
Table – Correlation between normative references and dated EN and ISO standards
Normative references Equivalent dated standard
as listed in Clause 2 of the ISO
EN ISO
standard
ISO 9000:2015 EN ISO 9000:2015 ISO 9000:2015
Endorsement notice
The text of ISO 13485:2016 has been approved by CEN as EN ISO 13485:2016/prA1:2019 without any
modification.
3
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SIST EN ISO 13485:2016/oprA1:2019
EN ISO 13485:2016/prA1:2019 (E)
Annex ZA
(informative)
Relationship between this European Standard and the conformity
assessment requirements of EU Directive 90/385/EEC on active
implantable medical devices [OJ L 189] (as amended) aimed to be
covered
This European standard has been prepared under a Commission’s standardisation request M/023 to
provide one voluntary means of conforming to essential requirements of Council Directive 90/385/EEC
of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable
medical devices [OJ L 189] (as amended).
Once this standard is cited in the Official Journal of the European Union under that Directive, compliance
with the normative clauses of this standard given in Tables ZA.1 or ZA.2 confers, within the limits of the
scope of this standard, a presumption of conformity with the corresponding conformity assessment
requirements of that Directive and associated EFTA regulations.
The Conformity Assessment Annexes 2 and 5 of the Directive include description of the regulatory
process and activities undertaken by the Notified Body, which both are outside of the scope of this
European Standard and therefore not covered by this European Standard. Furthermore, the
requirements of the Directive refer to an application to a Notified Body, not to the requirement for a
quality system as such. Accordingly, coverage of legal requirements can only be presumed to the extent
listed in Tables ZA.1 and ZA.2 if an application to a Notified Body:
— contains the necessary quality system documentation;
— has been reviewed and approved by a Notified Body,
and the undertakings listed in the application are correctly executed by the manufacturer.
NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk
management process needs to be in compliance with 90/385/EEC, as amended by 2007/47/EC. This means that
risks have to be reduced ‘as far as possible’, ‘to a minimum’, ‘to the lowest possible level’, ‘minimized’ or ‘removed’,
according to the wording of the corresponding essential requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with essential
requirements 1, 4, 5, 8, 9 and 10of the Directive.
NOTE 3 This Annex ZA is based on normative references according to the table of references in the European
foreword, replacing the references in the core text.
NOTE 4 When a requirement does not appear in Tables ZA.1 or ZA.2, it means that it is not addressed by this
European Standard.
NOTE 5 This annex uses the term “quality system” as used in the Directive whereas this European Standard uses
the term “quality management system” in accordance with ISO terminology.
4
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SIST EN ISO 13485:2016/oprA1:2019
EN ISO 13485:2016/prA1:2019 (E)
ZA.1 Relationship with Annex 2 of Directive 90/385/EEC (as amended)
Compliance with this European Standard does not provide presumption of conformity with all the
aspects of Annex 2, as outlined in Table ZA.1. Therefore, a manufacturer or a Notified Body has to take
additional provisions to ensure conformity, and claim or certify conformance, with Annex 2 of this
Directive. The legal requirements must be examined, applied and verified one by one and the solutions
adopted must become part of the quality system in the meaning of the Directive.
Table ZA.1 — Correspondence between this European Standard and Annex 2 of Directive
90/385/EEC [OJ L 189] (as amended)
Paragraph of Directive
Clauses of this EN Qualifying remarks/Notes
90/385/EEC, Annex 2
st
3.1, 1 sentence Not covered.
nd st
3.1, 2 sentence, 1 indent Not covered.
nd nd 4.1.1, 4.1.2, 4.1.3, Covered. The documentation
3.1, 2 sentence, 2 indent
4.1.4, 4.1.6, 4.2.1, required in this European Standard
4.2.2, 4.2.3, 4.2.4, covers the quality system
documentation meant in 3.2 of
4.2.5
Annex 2 when the explicit legal
requirements are incorporated into
the quality system documentation.
See also coverage of 3.2 below.
nd rd
3.1, 2 sentence, 3 indent 4.1, 5.1, 5.4, 5.5, 5.6 Covered in part. This European
Standard requires top management
commitment to implementation of
the quality system and that
documented procedures are
implemented but does not require a
signed undertaking.
nd th
3.1, 2 sentence, 4 indent 4.1, 5.1, 5.4, 5.5, 5.6 Covered in part. This European
Standard requires maintenance of
the approved quality system but
does not require a signed
undertaking.
nd th
3.1, 2 sentence, 5 indent Not covered. This European
Standard includes requirements on
post-market surveillance, and
reporting adverse events and field
safety corrective actions to
authorities but does not cover all the
details required by the Directive
including timescales for reporting.
st
3.2, 1 paragraph Not covered. The application of this
European Standard does not by
itself ensure the fulfilment of all
regulatory requirements of the
Directive. The legal requirements
must be examined, applied and
verified one by one and the
solutions adopted become part of
the quality system in the meaning of
the Directive.
nd st
3.2, 2 paragraph, 1 sentence 4.1, 4.2 Covered.
5
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SIST EN ISO 13485:2016/oprA1:2019
EN ISO 13485:2016/prA1:2019 (E)
Paragraph of Directive
Clauses of this EN Qualifying remarks/Notes
90/385/EEC, Annex 2
nd nd
3.2, 2 paragraph, 2 sentence 4.1, 4.2 Covered.
nd rd
3.2, 2 paragraph, 3 sentence 4.1, 4.2, 7 Covered provided quality
management system documentation
makes possible a uniform
interpretation of the quality policies
and procedures, such as quality
programs, quality plans, quality
manuals and quality records, and
that the applicable documentation
listed in 3.2 of Annex 2 is
incorporated into the quality system
documentation.
rd
3.2, 3 paragraph (a) 4.2.1, 4.2.3, 5.1, 5.3, 5.4.1 Covered.
rd
3.2, 3 paragraph (b) 4.2.2, 5.1 Covered.
rd st
3.2, 3 paragraph (b), 1 indent 4.2.2, 5.1, 5.5.1, 5.5.2 Covered.
rd nd
3.2, 3 paragraph (b), 2 indent 4.1, 5.6, 7.1, 8.2.4, 8.3, 8.4, 8.5.2, Covered provided that the methods
8.5.3 and acceptance criteria chosen by
the manufacturer ensure that the
requirements of the Directive are
fulfilled.
rd rd
3.2 3 paragraph (b) 3 indent 4.1, 4.2, 7.4, 8.2.2 Covered.
rd st
3.2 3 paragraph (c) 1 indent 4.2, 7.3.2, 7.3.3, 7.3.7, 7.3.9, 7.3.10 Covered provided that the
applicable quality management
system documentation includes
design specifications identifying
standards which will be applied and
a description of the solutions
adopted to fulfil the essential
requirements which apply when
harmonized standards are not
applied in full.
rd nd
3.2, 3 paragraph (c), 2 indent 7.3.1, 7.3.6, 7.3.7, 7.3.9 Covered.
rd rd
3.2, 3 paragraph (c), 3 indent Not covered.
rd th
3.2, 3 paragraph (c), 4 indent 7.3.6, 7.3.7 Covered provided that the quality
management system
records include the pre-clinical
evaluation.
rd th
3.2, 3 paragraph (c), 5 indent Not covered. Clause 7.3.7 does not
include the details of Annex 7.
rd st
3.2, 3 paragraph (d), 1 indent 4.2, 6.4, 7.1, 7.4 7.5 Covered provided that the quality
management system
documentation includes relevant
documents and records in regards to
sterilization and purchasing.
rd nd
3.2, 3 paragraph (d), 2 indent 4.2, 7.5.8, 7.5.9 Covered.
rd
3.2, 3 paragraph (e) 4.2, 7.1, 7.4.3, 7.5.9.1, 7.6, 8.2.6 Covered provided that the
documented frequency at which
tests are carried out is detailed in
the quality management
system documentation.
6.1 Not covered. The specific time
periods in Directive are not
specified in 4.2.4 or 4.2.5.
6
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SIST EN ISO 13485:2016/oprA1:2019
EN ISO 13485:2016/prA1:2019 (E)
ZA.2 Relationship with Annex 5 of Directive 90/385/EEC (as amended)
Compliance with this European Standard does not provide presumption of conformity with all the
aspects of Annex 5, as outlined in Table ZA.2. Therefore, a manufacturer or a Notified Body has to take
additional provisions to ensure conformity, and claim or certify conformance, with Annex 5 of this
Directive. The legal requirements must be examined, applied and verified one by one and the solutions
adopted must become part of the quality system in the meaning of the Directive.
Table ZA.2 — Correspondence between this European Standard and Annex 5 of Directive
90/385/EEC (as amended)
Paragraph of Directive
Clauses of this EN Qualifying remarks/Notes
90/385/EEC, Annex 5
st
3.1, 1 paragraph Not covered.
nd st
3.1, 2 paragraph, 1 indent Not covered.
nd nd 4.1, 4.2 Covered. The documentation
3.1, 2 paragraph, 2 indent
required in this European Standard
covers the quality system
documentation meant in 3.2 of
Annex 5 when the explicit legal
requirements are incorporated into
the quality system documentation.
See also coverage of 3.2 below.
nd rd 4.1, 5.1, 5.4, 5.5, 5.6 Covered.
3.1, 2 paragraph, 3 indent
4.1, 5.1, 5.4, 5.5, 5.6 Covered.
nd th
3.1, 2 paragraph, 4 indent
4.1, 4.2 Covered in part provided that
nd th
3.1, 2 paragraph, 5 indent
quality management system
includes the technical
documentation relating to the
applicable approved type(s) of
medical device(s).
Reference to the EC type-
examination certificate is not
covered.
Not covered. This European
nd th
3.1, 2 paragraph, 6 indent
Standard includes requirements on
post market surveillance, and
reporting adverse events and field
safety corrective actions to
authorities but does not cover all the
details required by the Directive
including timescales for reporting
st Not covered. Reference to the EC
3.2, 1 paragraph
type-examination certificate is not
covered.
4.1, 4.2 Covered.
nd
3.2, 2 paragraph
rd 4.2.1, 5.1, 5.3, 5.4.1 Covered.
3.2, 3 paragraph (a)
rd st
3.2, 3 paragraph (b), 1 indent 5.5.1, 5.5.2 Covered.
7
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SIST EN ISO 13485:2016/oprA1:2019
EN ISO 13485:2016/prA1:2019 (E)
Paragraph of Directive
Clauses of this EN Qualifying remarks/Notes
90/385/EEC, Annex 5
rd nd
3.2, 3 paragraph (b), 2 indent 4.1, 5.6, 7.1, 8.2.4, 8.3, 8.4, 8.5.2, Covered provided that the methods
8.5.3 and acceptance criteria chosen by
the manufacturer ensure that the
requirements of the Directive are
fulfilled.
rd rd
3.2, 3 paragraph (b), 3 indent 4.1, 4.2, 7.4, 8.2.2 Covered.
rd st
3.2, 3 paragraph (c), 1 indent 4.2, 6.4, 7.1, 7.4, 7.5, 8.2.5 Covered provided that the quality
management system documentation
includes relevant documents and
records in regards to sterilization
and purchasing.
rd nd
3.2, 3 paragraph (c), 2 indent 4.2, 7.5.8, 7.5.9 Covered.
rd
3.2, 3 paragraph (d) 7.1, 7.4.3, 7.6, 8.2.6 Covered provided that the
frequency at which tests are carried
out is documented in the quality
management system
documentation.
WARNING 1 — Presumption of conformity stays valid only as long as a reference to this European
Standard is maintained in the list published in the Official Journal of the European Union. Users of this
standard should consult frequently the latest list published in the Official Journal of the European Union.
WARNING 2 — Other Union legislation may be applicable to the products falling within the scope of this
standard.
8
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SIST EN ISO 13485:2016/oprA1:2019
EN ISO 13485:2016/prA1:2019 (E)
Annex ZB
(informative)
Relationship between this European Standard and the conformity
assessment requirements of EU Directive 93/42/EEC on medical
devices [OJ L 169] (as amended) aimed to be covered
This European Standard has been prepared under a Commission's standardization request M/023 to
provide one voluntary means of conforming to essential requirements of Council Directive 93/42/EEC of
14 June 1993 concerning medical devices [OJ L 169 (as amended)].
Once this standard is cited in the Official Journal of the European Union under that Directive, compliance
with the normative clauses of this standard given in Tables ZB.1, ZB.2 or ZB.3 confers, within the limits
of the scope of this standard, a presumption of conformity with the corresponding conformity assessment
requirements of that Directive and associated EFTA regulations.
The Conformity Assessment Annexes II, V and VI of the Directive include description of the regulatory
process and activities undertaken by the Notified Body, which both are outside of the scope of this
European Standard and therefore not covered by this European Standard. Furthermore, the
requirements of the Directive refer to an application to a Notified Body, not to the requirement for a
quality system as such. Accordingly, coverage of legal requirements can only be presumed to the extent
listed in Tables ZB.1, ZB.2 and ZB.3 if an application to a Notified Body:
— contains the necessary quality system documentation;
— has been reviewed and approved by a Notified Body,
and the undertakings listed in the application are correctly executed by the manufacturer.
NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk
management process needs to be in compliance with 93/42/EEC, as amended by 2007/47/EC. This means that
risks have to be reduced ‘as far as possible’, ‘to a minimum’, ‘to the lowest possible level’, ‘minimized’ or ‘removed’,
according to the wording of the corresponding essential requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with essential
requirements 1, 2, 5, 6, 7, 8, 9, 11 and 12 of the Directive.
NOTE 3 This Annex ZB is based on normative references according to the table of references in the European
foreword, replacing the references in the core text.
NOTE 4 When a requirement does not appear in Tables ZB.1, ZB.2 or ZB.3 it means that it is not addressed by
this European Standard.
NOTE 5 This annex uses the term “quality system” as used in the Directive whereas this European Standard uses
the term “quality management system” in accordance with ISO terminology.
ZB.1 Relationship with Annex II of Directive 93/42/EEC (as amended)
Compliance with this European Standard does not provide a presumption of conformity with all the
aspects of Annex II, as outlined in Table ZB.1. Therefore, a manufacturer or a Notified Body has to take
additional provisions to ensure conformity, and claim or certify conformance, with Annex II of this
Directive. The legal requirements must be examined, applied and verified one by one and the solutions
9
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SIST EN ISO 13485:2016/oprA1:2019
EN ISO 13485:2016/prA1:2019 (E)
adopted must become part of the quality system in the meaning of the Directive.
Table ZB.1 — Correspondence between this European Standard and Annex II of Directive
93/42/EEC [OJ L 169] (as amended)
Paragraph of Directive
Clauses of this EN Qualifying remarks/Notes
93/42/EEC, Annex II
3.1, 1st sentence Not covered.
nd st
3.1, 2 sentence, 1 indent
Not covered.
nd nd
3.1, 2 sentence, 2 indent
Not covered.
nd rd
3.1, 2 sentence, 3 indent
Not covered.
nd th
3.1, 2 sentence, 4 indent 4.1, 4.2 Covered. The documentation
required in this European
Standard covers the quality system
documentation meant in 3.2 of
Annex II when the explicit legal
requirements are incorporated into
the quality system documentation.
See also coverage of 3.2 below.
nd th
3.1, 2 sentence, 5 indent 4.1, 5.1, 5.4, 5.5, 5.6 Covered.
nd th
3.1, 2 sentence, 6 indent 4.1, 5.1, 5.4, 5.5, 5.6 Covered.
nd th
3.1, 2 sentence, 7 indent Not covered. This European
th
3.1, 7 indent (i) Standard includes requirements on
th
3.1, 7 indent (ii) post market surveillance, and
reporting adverse events and field
safety corrective actions to
authorities but does not cover all the
details required by the Directive
including timescales for reporting.
st st
3.2, 1 paragraph, 1 sentence Not covered. The application of this
European Standard does not by
itself ensure the fulfilment of all
regulatory requirements of the
Directive. The legal requirements
must be examined, applied and
verified one by one and the
solutions adopted become part of
the quality system in the meaning of
the Directive.
st nd
3.2, 1 paragraph, 2 sentence 4.1, 4.2, 7.1. Covered.
nd
3.2, 2 paragraph 4.1, 4.2, 7 Covered provided quality
management system documentation
makes possible a uniform
interpretation of the quality policies
and procedures, such as quality
programs, quality plans, quality
manuals and quality records, and
that the applicable documentation
listed in 3.2 of Annex II is
incorporated into the quality system
documentation.
rd
3.2, 3 paragraph (a) 4.2.1, 5.1, 5.3, 5.4.1 Covered.
rd
3.2, 3 paragraph (b) 4.2.2, 5.1 Covered.
rd st
3.2, 3 paragraph (b), 1 indent 4.2.2, 5.1, 5.5.1, 5.5.2 Covered.
10
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SIST EN ISO 13485:2016/oprA1:2019
EN ISO 13485:2016/prA1:2019 (E)
Paragraph of Directive
Clauses of this EN Qualifying remarks/Notes
93/42/EEC, Annex II
rd nd
3.2, 3 paragraph (b), 2 indent 4.1, 5.6, 7.1, 8.2.4, 8.3, 8.4, 8.5.2, Covered provided that the methods
8.5.3 and acceptance criteria chosen by
the manufacturer ensure that the
requirements of the Directive are
fulfilled.
rd rd
3.2, 3 paragraph (b), 3 indent 4.1, 4.2, 7.4, 8.2.2 Covered.
rd
3.2, 3 paragraph (c) 7.1, 7.2, 7.3 Covered.
rd st
3.2, 3 paragraph (c), 1 indent 4.2.3, 7.2, 7.3.3, 7.3.4, 7.3.10 Covered provided that the
documentation containing a
general description of the medical
device includes any
variants.
rd nd
3.2, 3 paragraph (c), 2 indent 4.2, 7.3.3, 7.3.4, 7.3.6, 7.3.8 Covered provided that the
applicable quality management
system documentation includes
design specifications identifying
standards which will be applied and
a description of the solutions
adopted to fulfil the essential
requirements which apply when
harmonized standards are not
applied in full.
rd rd
3.2, 3 paragraph (c), 3 indent 7.3.1, 7.3.6, 7.3.7, 7.3.8, 7.3.9, 7.3.10 Covered.
rd th
3.2, 3 paragraph (c), 4 indent 7.3.2, 7.3.3, 7.3.5, 7.3.6 Covered.
rd th
3.2, 3 paragraph (c), 5 indent 4.2.3 Covered provided that the quality
management system documentation
includes a statement indicating
whether or not the medical device
incorporates, as an integral part,
a substance or a human blood
derivative and the data on the tests
conducted in this connection
required to assess the safety, quality
and usefulness of that substance or
human blood derivative, taking
account of the intended purpose of
the medical device.
rd th
3.2, 3 paragraph (c), 6 indent 4.2.3 Covered provided that the quality
management system documentation
includes a statement indicating
whether or not the device is
manufactured utilizing tissues of
animal origin as referred to in
Commission Directive 2003/32/EC.
th
3.2, 3rd paragraph (c), 7 indent Not covered.
rd th
3.2, 3 paragraph (c), 8 indent 7.3.6, 7.3.7 Covered provided that the quality
management system
records include the pre-clinical
evaluation.
rd th
3.2, 3 paragraph (c), 9 indent Not covered. 7.3.7 does not include
the details of Annex X.
11
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SIST EN ISO 13485:2016/oprA1:2019
EN ISO 13485:2016/prA1:2019 (E)
Paragraph of Directive
Clauses of this EN Qualifying remarks/Notes
93/42/EEC, Annex II
rd th
3.2, 3 paragraph (c), 10 indent 4.1, 4.2, 7 Covered provided that the quality
management system documentation
includes the label and, where
appropriate, instructions for use.
rd
3.2, 3 paragraph (d) 4.2, 7.1, 7.5, 7.6, 8.1, 8.2.5, 8.2.6 Covered.
rd st
3.2, 3 paragraph (d), 1 indent, 4.1.1, 6.4, 7.5 Covered.
sterilization
rd st
3.2, 3 paragraph (d), 1 indent, 4.1.1, 7.4 Covered.
purchasing
rd st
3.2, 3 paragraph (d), 1 indent, 4.2, 7.1 Covered provided that the quality
relevant documents management system
documentation includes relevant
documents and records
in regards to sterilization and
purchasing.
rd nd
3.2, 3 paragraph (d), 2 indent 4.2, 7.5.8, 7.5.9 Covered.
rd
3.2, 3 paragraph (e) 4.2, 7.1, 7.4.3, 7.5.9.1, 7.6, 8.2.6 Covered provided that the
documented frequency at which
tests are carried out is detailed in
the quality management system
documentation.
6.1 Not covered. The specific time
periods in Directive are not
Specified in 4.2.4 and 4.2.5
ZB.2 Relationship with Annex V of Directive 93/42/EEC (as amended)
Compliance with this European Standard does not provide presumption of conformity with all the
aspects of Annex V, as outlined in Table ZB.2. Therefore, a manufacturer or a Notified Body has to take
additional provisions to ensure conformity, and claim or certify conformance, with Annex V of this
Directive. The legal requirements must be examined, applied and verified one by one and the solutions
adopted must become part of the quality system in the meaning of the Directive.
Table ZB.2 — Correspondence between this European Standard and Annex V of Directive
93/42/EEC (as amended)
Paragraph of Directive
Clauses of this EN Qualifying remarks/Notes
93/42/EEC, Annex V
st
3.1 1 paragraph Not covered.
nd st
3.1 2 paragraph 1 indent
Not covered.
nd nd
3.1 2 paragraph 2 indent
Not covered.
nd rd
3.1 2 paragraph 3 indent
Not covered.
12
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SIST EN ISO 13485:2016/oprA1:2019
EN ISO 13485:2016/prA1:2019 (E)
Paragraph of Directive
Clauses of this EN Qualifying remarks/Notes
93/42/EEC, Annex V
nd th
3.1 2 paragraph 4 indent Covered provided quality
4.1, 4.2
management system documentation
makes possible a uniform
interpretation of the quality policies
and procedures, such as quality
programs, quality plans, quality
manuals and quality records, and
that the applicable documentation
listed in 3.2 of Annex V is
incorporated into the quality system
documentation.
nd th
3.1 2 paragraph 5 indent Covered.
4.1, 5.1, 5.4, 5.5, 5.6
nd th
3.1 2 paragraph 6 indent Covered.
4.1, 5.1, 5.4, 5.5, 5.6
nd th
3.1 2 paragraph 7 indent Covered in part provided that
4.1, 4.2
q
...
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