SIST EN ISO 13485:2016/kprA1:2021

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 (ISO 13485:2016)

General Information

• Status: Not Published
• Public Enquiry End Date: 19-Dec-2019
• ICS: 03.100.70 - Management systems
• ICS: 11.020.01 - Quality and environmental management in health care
• Technical Committee: VAZ - Healthcare
• Current Stage: 5020 - Formal vote (FV) (Adopted Project)
• Start Date: 03-Feb-2021
• Due Date: 24-Mar-2021
• Completion Date: 03-Feb-2021
• Directive: 2017/745 - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
• Directive: 2017/746 - Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU
• Directive: 90/385/EEC - 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
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Directive: 98/79/EC - Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices
• Mandate: M/MDR - Medical devices and in vitro diagnostic medical devices in support of Regulation (EU) 2017/745 of the European Parliament and of the Council and Regulation (EU) 2017/746
• Ref Project: EN ISO 13485:2016/FprA11 - Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

RELATIONS

• Amends: SIST EN ISO 13485:2016 - Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
• Effective Date: 01-Dec-2019

Standards Content (sample)

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.

---------------------- Page: 1 ----------------------
SIST EN ISO 13485:2016/oprA1:2019
---------------------- Page: 2 ----------------------
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.
---------------------- Page: 3 ----------------------
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

---------------------- Page: 4 ----------------------
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.
---------------------- Page: 5 ----------------------
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.
---------------------- Page: 6 ----------------------
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
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.
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.
---------------------- Page: 7 ----------------------
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.
3.2, 3 paragraph (a) 4.2.1, 4.2.3, 5.1, 5.3, 5.4.1 Covered.
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.

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.
---------------------- Page: 8 ----------------------
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
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.
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.
---------------------- Page: 9 ----------------------
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.
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.
---------------------- Page: 10 ----------------------
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

---------------------- Page: 11 ----------------------
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
3.1, 7 indent (i) Standard includes requirements on
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.
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.
3.2, 3 paragraph (a) 4.2.1, 5.1, 5.3, 5.4.1 Covered.
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.
---------------------- Page: 12 ----------------------
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.
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.
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.
---------------------- Page: 13 ----------------------
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.
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.

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
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.
---------------------- Page: 14 ----------------------
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
...