SIST-TP CEN/TR 17223:2018
(Main)Guidance on the relationship between EN ISO 13485: 2016 (Medical devices - Quality management systems - Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation
Guidance on the relationship between EN ISO 13485: 2016 (Medical devices - Quality management systems - Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation
This Technical Report provides guidance on the relationship between the requirements in the European Regulations for Medical Device and In Vitro Diagnostic Medical Devices and EN ISO 13485:2016 - Medical devices - Quality management systems - Requirements for regulatory purposes.
Leitfaden zum Zusammenhang zwischen EN ISO 13485: 2016 (Medizinprodukte - Qualitätsmanagementsysteme - Anforderungen für regulatorische Zwecke) und den europäischen Verordnungen über Medizinprodukte und In-vitro-Diagnostika
Document d’orientation sur la relation entre l’EN ISO 13485: 2016 (Dispositifs médicaux - Systèmes de management de la qualité - Exigences à des fins réglementaires) et le Règlement européen relatif aux dispositifs médicaux ainsi que le Règlement relatif aux dispositifs médicaux de diagnostic in vitro
Le présent Rapport technique fournit des recommandations relatives à la relation entre l’EN ISO 13485:2016 (Dispositifs médicaux — Systèmes de management de la qualité — Exigences à des fins réglementaires) et les exigences présentées dans le Règlement (UE) 2017/745 relatif aux dispositifs médicaux et au Règlement (UE) 2017/746 relatif aux dispositifs médicaux de diagnostic in vitro.
Navodilo za povezavo med EN ISO 13485:2016 (Medicinski pripomočki - Sistemi vodenja kakovosti - Zahteve za zakonodajne namene) ter Uredbo (EU) o medicinskih pripomočkih in Uredbo (EU) o in vitro diagnostičnih medicinskih pripomočkih
To tehnično poročilo vsebuje smernice glede razmerja med zahtevami v evropskih uredbah o medicinskih pripomočkih ter in-vitro diagnostičnih medicinskih pripomočkih in standardom EN ISO 13485:2016 - Medicinski pripomočki - Sistemi vodenja kakovosti - Zahteve za zakonodajne namene.
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
SIST-TP CEN/TR 17223:2018
01-maj-2018
1DYRGLOR]DSRYH]DYRPHG(1,62 0HGLFLQVNLSULSRPRþNL6LVWHPL
YRGHQMDNDNRYRVWL=DKWHYH]D]DNRQRGDMQHQDPHQH WHU8UHGER (8 R
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Guidance on the relationship between EN ISO 13485: 2016 (Medical devices - Quality
management systems - Requirements for regulatory purposes) and European Medical
Devices Regulation and In Vitro Diagnostic Medical Devices Regulation
Leitfaden zum Zusammenhang zwischen EN ISO 13485: 2016 (Medizinprodukte -
Qualitätsmanagementsysteme - Anforderungen für regulatorische Zwecke) und den
europäischen Verordnungen über Medizinprodukte und In-vitro-Diagnostika
Document d’orientation sur la relation entre l’EN ISO 13485: 2016 (Dispositifs médicaux -
Systèmes de management de la qualité - Exigences à des fins réglementaires) et le
Règlement européen relatif aux dispositifs médicaux ainsi que le Règlement relatif aux
dispositifs médicaux de diagnostic in vitro
Ta slovenski standard je istoveten z: CEN/TR 17223:2018
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-TP CEN/TR 17223:2018 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST-TP CEN/TR 17223:2018
TECHNICAL REPORT
CEN/TR 17223
RAPPORT TECHNIQUE
TECHNISCHER BERICHT
March 2018
ICS 03.100.70; 11.040.01
English version
Guidance on the relationship between EN ISO 13485: 2016
(Medical devices - Quality management systems -
Requirements for regulatory purposes) and European
Medical Devices Regulation and In Vitro Diagnostic
Medical Devices Regulation
Document d'orientation sur la relation entre l'EN ISO Leitfaden zum Zusammenhang zwischen EN ISO
13485: 2016 (Dispositifs médicaux - Systèmes de 13485: 2016 (Medizinprodukte -
management de la qualité - Exigences à des fins Qualitätsmanagementsysteme - Anforderungen für
réglementaires) et le Règlement européen relatif aux regulatorische Zwecke) und den europäischen
dispositifs médicaux ainsi que le Règlement relatif aux Verordnungen über Medizinprodukte und In-vitro-
dispositifs médicaux de diagnostic in vitro Diagnostika
This Technical Report was approved by CEN on 12 February 2018. It has been drawn up by the Technical Committee
CEN/CLC/JTC 3.
CEN and CENELEC members are the national standards bodies and national electrotechnical committees of Austria, Belgium,
Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany,
Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania,
Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.
CEN-CENELEC Management Centre:
Rue de la Science 23, B-1040 Brussels
© 2018 CEN/CENELEC All rights of exploitation in any form and by any means Ref. No. CEN/TR 17223:2018 E
reserved worldwide for CEN national Members and for
CENELEC Members.
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Contents Page
European Foreword . 3
Introduction . 4
1 Scope . 7
2 Normative references. 7
3 Terms and definitions . 7
4 Relationship between the European Regulations for Medical Devices and in vitro Diagnostic
Medical Devices and the clauses of EN ISO 13485 . 7
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European Foreword
This document (CEN/TR 17223:2018) has been prepared by Technical Committee CEN/CLC/JTC 3,
“Quality management and corresponding general aspects for medical devices”, the secretariat of
which is held by NEN.
Attention is drawn to the possibility that some of the elements of this document may be the subject
of patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
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Introduction
This Technical Report has been prepared to provide guidance on the relationship between
EN ISO 13485:2016 (Medical devices – Quality management systems – Requirements for regulatory
purposes) and the requirements in the European Regulations on Medical Devices (MDR)- Regulation
(EU) 2017/745 - and in vitro Diagnostic Medical Devices (IVDR) -Regulation (EU) 2017/746.
EN ISO 13485 describes a quality management system that is applicable to medical devices and is
intended for regulatory purposes. The European Regulations for medical devices and EN ISO 13485
present holistic requirements for systematic application of a process approach to quality
management into which an organization can incorporate regulatory requirements that are
applicable to its activities. As the requirements are integrated and build on each other, all the
requirements applicable to the organizations’ activities and the applicable regulatory requirements
need to be applied. It is not intended that requirements are implemented in isolation from the
complete system. While this Technical Report describes the interrelationship of individual
paragraphs, or parts of a paragraph, of the Regulations with particular subclauses of EN ISO 13485,
this is not intended to imply that these subclauses can be implemented in the absence of the entire
quality management system described in the standard.
This Technical Report focuses on the general obligations of the manufacturer (Article 10) and the
conformity assessment requirements (Annexes IX and XI) of the European Regulations for Medical
Devices and in vitro Diagnostic Medical Devices. Compliance with all the normative clauses in
EN ISO 13485 will ensure that a process is in place to address quality management system aspects
related to medical devices, which are included in Article 10 and Annexes IX and XI of the
Regulations.
Generally, it is not meaningful to link individual clauses of EN ISO 13485 to specific general safety
and performance requirements (Annex I). The General Requirements in Chapter 1 of Annex 1,
however, relate to the application of risk and the requirements for the manufacturer to implement
a risk management system. As the general obligation of the manufacturer in Article 10 requires the
implementation of a risk management system and EN ISO 13485 requires processes for risk
management in product realization, the relationships between Chapter 1 in the general safety and
performance requirements and the corresponding subclauses of EN ISO 13485:2016 are included
in this Technical Report. Specific details of a risk management system for medical devices are
provided in EN ISO 14971.
The scope of EN ISO 13485 indicates that the standard can be applied by:
— organizations involved in one or more stages of the life-cycle, including design and
development, production, storage and distribution, installation, or servicing of a medical device
and design and development or provision of associated activities (e.g. technical support), and
— suppliers or external parties that provide product, including quality management system-
related services, to such organizations.
As such, EN ISO 13485 may be applied by other economic operators in the supply chain such as
authorized representatives, importers, distributors or assemblers of systems or procedure packs.
Consequently, EN ISO 13485 can also support meeting the regulatory obligations for authorized
representatives (Article 11), Importers (Article 13), Distributors (Article 14) or assemblers of
systems or procedure packs (MDR Article 22).
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However, because this is an adoption of an international standard, intended to be applicable in
jurisdictions all over the world, it is not the primary goal of the standard to cover exactly the
European quality management system requirements. Therefore, 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 feed the
quality management system requirements in the applicable European Regulation into the processes
provided by EN ISO 13485.
For example, Article 15 of the European Regulations define specific requirements for a position of
‘person responsible for regulatory compliance’. While this position is not explicitly mentioned in
EN ISO 13485, it constitutes a regulatory requirement that would need to be incorporated into the
quality management system of an organization seeking to comply with the Regulations. Once
incorporated into the quality management system, related requirements, for example for
competence, definition of responsibilities and interrelationships, would apply to this position.
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.
Explanation on the relationship between the requirements of EN ISO 13485 and:
— European Regulations on Medical Devices (Regulation (EU) 2017/745) is provided in this
Technical Report in Table 1; and,
— European Regulations on in vitro Diagnostic Medical Devices (Regulation (EU) 2017/746) is
provided in this Technical Report in Table 2.
NOTE 1 When a requirement does not appear in Table 1 or Table 2, it means that it is not addressed by
EN ISO 13485:2016.
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 2 In many places, Annex XI of the European regulations refers back to paragraphs in Annex IX. In
Tables 1 and 2, the applicable text from Annex IX is incorporated under the reference for Annex XI.
Article 8 of the European Regulations (Use of harmonized standards), indicates that system or
process requirements to be fulfilled by economic operators, such as requirements for quality
management systems, are to be presumed to be fulfilled if the system or process is in conformance
with a relevant harmonized standard. A standard is given the status of being harmonized by
publication of a reference in the Official Journal of the European Union under European Regulations
for Medical Devices and in vitro Diagnostic Medical Devices. For a harmonized standard,
presumption of conformity with the identified requirements of these Regulations is provided by
compliance with the normative clauses given in the table or tables in the Annex Z of a standard,
within the limits of the scope of the standard, once that standard has been implemented as a
national standard in at least one Member State. The Annex Z explains to which requirements, under
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which conditions and to what extent, presumption of conformity can be claimed. Inclusion of a
standard the Official Journal of the European Union and the preparation, agreement and publication
of an Annex Z requires a mandate being given to a European Standards Body by the European
Commission.
In advance of such a mandate, this Technical Report has been prepared to provide guidance to
manufacturers and conformity assessment bodies on the relationship between EN ISO 13485:2016
and the European Regulations for Medical Devices and in vitro Diagnostic Medical Devices. This
Technical Report does not imply that compliance with EN ISO 13485 provides a presumption of
conformity with the requirements of the European Regulations for Medical Devices or in vitro
Diagnostic Medical Devices.
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1 Scope
This Technical Report provides guidance on the relationship between EN ISO 13485:2016, Medical
devices – Quality management systems – Requirements for regulatory purposes and the requirements
in EU Regulation 2017/745 on Medical Devices and EU Regulation 2017/746 on in vitro Diagnostic
Medical Devices.
2 Normative references
The following referenced document is indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the
referenced document (including any amendments) applies.
EN ISO 13485:2016, Medical devices - Quality management systems - Requirements for regulatory
purposes (ISO 13485:2016)
3 Terms and definitions
For the purposes of this Technical Report, the terms and definitions in EN ISO 13485 apply.
4 Relationship between the European Regulations for Medical Devices and in
vitro Diagnostic Medical Devices and the clauses of EN ISO 13485
Table 1 shows the relationship between the clauses of EN ISO 13485 and the requirements of the
European Regulations on Medical Devices (Regulation (EU) 2017/745), together with commentary
on the extent to which the requirements of the standard cover the specific details in the Regulation.
Table 2 shows the relationship between the clauses of EN ISO 13485 and the requirements of the
European Regulations on in vitro Diagnostic Medical Devices (Regulation (EU) 2017/746), together
with commentary on the extent to which the requirements of the standard cover the specific details
in the Regulation.
Following the content of this Technical Report does not infer compliance with the specific quality
management system requirements of the European Regulations; it serves as tool for understanding
the links and connection between EN ISO 13485 and the European Regulations.
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Table 1 — The relationship between the clauses of EN ISO 13485 and the requirements of the European Regulations on Medical
Devices (EU Regulation 2017/745) Article 10, Annex 1 Chapter 1, Annex IX and Annex XI
MDR Article MDR Annex ISO 13485
MDR Article 10 text MDR Annex text Comments
10 reference reference reference
1. When placing their devices 4.1, 7.1, Covered. EN ISO 13485
on the market or putting 7.2.1 c), includes requirements for
them into service, 7.2.2 c), 7.3, the QMS, design and
manufacturers shall ensure 7.5 development and
that they have been manufacturing that require
designed and manufactured incorporation of regulatory
in accordance with the requirements into the quality
requirements of this management system.
Regulation.
Annex I, Devices shall achieve the performance 7.1, 7.3, 7.5 Partially covered.
Chapter 1, intended by their manufacturer and EN ISO 13485 includes
shall be designed and manufactured in requirements to apply risk
1.
such a way that, during normal management in product
conditions of use, they are suitable for realization. The detail of the
their intended purpose. They shall be specific requirements of
safe and effective and shall not Annex 1, Chapter 1 of the
compromise the clinical condition or Regulation is not stated
the safety of patients, or the safety and explicitly.
health of users or, where applicable,
EN ISO 14971:2012 Medical
other persons, provided that any risks
devices - Application of Risk
which may be associated with their use
Management is referenced in
constitute acceptable risks when
a NOTE and listed in the
weighed against the benefits to the
Bibliography of
patient and are compatible with a high
EN ISO 13485.
level of protection of health and safety,
taking into account the generally
acknowledged state of the art.
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MDR Article MDR Annex ISO 13485
MDR Article 10 text MDR Annex text Comments
10 reference reference reference
2. Manufacturers shall 7.1 Partially covered.
establish, document, EN ISO 13485 includes
implement and maintain a requirements to risk
system for risk management in product
management as described realization. The detail of the
in Section 3 of Annex I. specific requirements of
Annex 1, Chapter 1 of the
Regulation is not stated
explicitly.
Annex I, The requirement in this Annex to Not covered. EN ISO 13485
Chapter 1, 2. reduce risks as far as possible means includes requirements to
the reduction of risks as far as possible apply a risk-based approach
without adversely affecting the benefit- to the quality management
risk ratio. system and apply risk
management in product
realization. The detail of the
specific requirements of
Annex 1, Chapter 1 of the
Regulation is not stated
explicitly.
EN ISO 14971:2012 Medical
devices - Application of Risk
Management is referenced in
a NOTE and listed in the
Bibliography of
EN ISO 13485.
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MDR Article MDR Annex ISO 13485
MDR Article 10 text MDR Annex text Comments
10 reference reference reference
Annex I Manufacturers shall establish, 7.1 Partially covered.
Chapter I, 3 implement, document and maintain a EN ISO 13485 includes
risk management system. 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.
Risk management shall be understood 4.1.2, 7.1 Partially covered.
as a continuous iterative process EN ISO 13485 includes
throughout the entire lifecycle of a requirements to apply risk
device, requiring regular systematic management in product
updating. In carrying out risk realization. The detail of the
management manufacturers shall: specific requirements of
Annex 1, Chapter 1 of the
Regulation is not stated
explicitly.
EN ISO 14971:2012 Medical
devices - Application of Risk
Management is referenced in
a NOTE and listed in the
Bibliography of
EN ISO 13485.
(a) establish and document a risk Not covered
management plan for each device;
(b) identify and analyse the known and
foreseeable hazards associated with
each device;
(c) estimate and evaluate the risks
associated with, and occurring
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MDR Article MDR Annex ISO 13485
MDR Article 10 text MDR Annex text Comments
10 reference reference reference
during, the intended use and during
reasonably foreseeable misuse;
(d) eliminate or control the risks
referred to in point (c) in
accordance with the requirements
of Section 4;
(e) evaluate the impact of information 8.2.1, 7.3.9 Partially covered.
from the production phase and, in EN ISO 13485 requires a
particular, from the post-market documented procedure for
surveillance system, on hazards and the feedback of information from
frequency of occurrence thereof, on the production and post-
estimates of their associated risks, as product phase into the risk
well as on the overall risk, benefit-risk management system.
ratio and risk acceptability;
(f) based on the evaluation of the Not covered
impact of the information referred to in
point (e), if necessary amend control
measures in line with the requirements
of Section 4.
Annex I Risk control measures adopted by Not covered
Chapter I, 4. manufacturers for the design and
manufacture of the devices shall
conform to safety principles, taking
account of the generally acknowledged
state of the art. To reduce risks,
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MDR Article MDR Annex ISO 13485
MDR Article 10 text MDR Annex text Comments
10 reference reference reference
Manufacturers shall manage risks so
that the residual risk associated with
each hazard as well as the overall
residual risk is judged acceptable.
In selecting the most appropriate
solutions, manufacturers shall, in the
following order of priority:
(a) eliminate or reduce risks as far as
possible through safe design and
manufacture;
(b) where appropriate, take adequate
protection measures, including
alarms if necessary, in relation to
risks that cannot be eliminated; and
(c) provide information for safety 7.2.1b), d), Partially covered.
(warnings/precautions/contra- 7.2.2d), EN ISO 13485 requires the
indications) and, where appropriate, 7.3.4d) identification and provision
training to users. of user training and
information necessary for
safe use.
Manufacturers shall inform users of any Not covered
residual risks.
Annex I In eliminating or reducing risks related 7.3.3 Partially covered.
Chapter I, 5. to use error, the manufacturer shall: EN ISO 13485 identifies
usability as a specific design
(a) reduce as far as possible the risks
and development input.
related to the ergonomic features of the
Design and development
device and the environment in which
inputs link directly to design
the device is intended to be used
and development outputs
(design for patient safety), and
and requirements for
verification and validation.
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MDR Article MDR Annex ISO 13485
MDR Article 10 text MDR Annex text Comments
10 reference reference reference
(b) give consideration to the technical 7.2.1b), Partially covered.
knowledge, experience, education, 7.2.2d) EN ISO 13485 requires the
training and use environment, where identification and provision
applicable, and the medical and physical of user training.
conditions of intended users (design for
lay, professional, disabled or other
users).
Annex 1, The characteristics and performance of 4.2.4, 4.2.5, Partially covered.
Chapter I, 6. a device shall not be adversely affected 7.2.1, 7.3.6, EN ISO 13485 requires the
to such a degree that the health or 7.3.7, 7.5.11 definition of the lifetime of
safety of the patient or the user and, the medical device and
where applicable, of other persons are identification of delivery and
compromised during the lifetime of the post-delivery activities
device, as indicated by the necessary for the intended
manufacturer, when the device is use.
subjected to the stresses which can
occur during normal conditions of use
and has been properly maintained in
accordance with the manufacturer's
instructions.
Annex 1, Devices shall be designed, 4.2.3c), Partially covered.
Chapter I, 7. manufactured and packaged in such a 7.5.11 EN ISO 13485 requires
way that their characteristics and protection during
performance during their intended use processing, storage, handling
are not adversely affected during and distribution.
transport and storage, for example,
through fluctuations of temperature
and humidity, taking account of the
instructions and information provided
by the manufacturer.
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MDR Article MDR Annex ISO 13485
MDR Article 10 text MDR Annex text Comments
10 reference reference reference
Annex 1, All known and foreseeable risks, and Not covered.
Chapter I, 8 any undesirable side-effects, shall be
minimized and be acceptable when
weighed against the evaluated benefits
to the patient and/or user arising from
the achieved performance of the device
during normal conditions of use.
Annex 1, For the devices referred to in Annex XVI Not covered.
Chapter I, 9. [Products without an intended medical
purpose], the general safety
requirements set out in Sections 1 and 8
shall be understood to mean that the
device, when used under the conditions
and for the purposes intended, does not
present a risk at all or presents a risk
that is no more than the maximum
acceptable risk related to the product's
use which is consistent with a high level
of protection for the safety and health of
persons.
3. MDR Manufacturers shall 7.3.7 Partially covered.
conduct a clinical evaluation EN ISO 13485 requires
in accordance with the clinical evaluation in
requirements set out in accordance with applicable
Article 61 and Annex XIV, regulatory requirements.
including a PMCF. The details contained in
Article 61 or Annex XIV are
not provided explicitly.
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MDR Article MDR Annex ISO 13485
MDR Article 10 text MDR Annex text Comments
10 reference reference reference
4. MDR Manufacturers of devices 4.2.3 Partially covered.
other than custom-made EN ISO 13485 requires that
devices shall draw up and the quality management
keep up to date technical system includes one or more
documentation for those files either containing or
devices. The technical referencing documents
documentation shall be generated to demonstrate
such as to allow the compliance with applicable
conformity of the device regulatory requirements. A
with the requirements of summary of the types of
this Regulation to be documents is provided. All
assessed. The technical the detail in Annexes II and
documentation shall include III is not provided explicitly.
the elements set out in
Annexes II and III.
Annex XI, the technical documentation referred to
Part A, 6.1, in Annexes II and III for the types
bullet 2. approved,
Annex XI,
Part B, 12,
Paragraph 2
The Commission is Not applicable to
empowered to adopt EN ISO 13485. Pertinent to
delegated acts in European Commission.
accordance with Article 115
amending, in the light of
technical progress, the
Annexes II and III.
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MDR Article MDR Annex ISO 13485
MDR Article 10 text MDR Annex text Comments
10 reference reference reference
5. Manufacturers of custom- 4.2.3 Partially covered.
made devices shall draw up, EN ISO 13485 requires that
keep up to date and keep the quality management
available for competent system includes one or more
authorities, documentation files either containing or
in accordance with Section referencing documents
2 of Annex XIII. 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. Where compliance with the Not covered. Preparation of
applicable requirements the EU declaration of
has been demonstrated conformity and affixing the
following the applicable CE mark is not covered in
conformity assessment EN ISO 13485.
procedure, manufacturers
of devices, other than
custom-made or
investigational devices,
shall draw up an EU
declaration of conformity in
accordance with Article 19,
and affix the CE marking of
conformity in accordance
with Article 20.
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MDR Article MDR Annex ISO 13485
MDR Article 10 text MDR Annex text Comments
10 reference reference reference
Annex XI, When the manufacturer fulfils the Not covered. Preparation of
Part A, 5 obligations laid down in [Annex XI] the EU declaration of
Section 4, it shall draw up and keep an conformity and affixing the
EU declaration of conformity in CE mark is not covered in
accordance with Article 19 and EN ISO 13485.
Annex IV for the device covered by the
conformity assessment procedure. By
issuing an EU declaration of conformity,
the manufacturer shall be deemed to
ensure and to declare that the device
concerned conforms to the type
described in the EU type-examination
certificate and meets the requirements
of this Regulation which apply to the
device.
7. Manufacturers shall comply 7.5.8 Partially covered.
with the obligations relating EN ISO 13485 includes a
to the UDI system referred requirement t
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Guidance on the relationship between EN ISO 13485: 2016 (Medical devices - Quality
management systems - Requirements for regulatory purposes) and European Medical
Devices Regulation and In Vitro Diagnostic Medical Devices Regulation
Leitfaden zum Zusammenhang zwischen EN ISO 13485: 2016 (Medizinprodukte -
Qualitätsmanagementsysteme - Anforderungen für regulatorische Zwecke) und den
europäischen Verordnungen über Medizinprodukte und In-vitro-Diagnostika
Ta slovenski standard je istoveten z: FprCEN/TR 17223
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
kSIST-TP FprCEN/TR 17223:2018 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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kSIST-TP FprCEN/TR 17223:2018
TECHNICAL REPORT
FINAL DRAFT
FprCEN/TR 17223
RAPPORT TECHNIQUE
TECHNISCHER BERICHT
November 2017
ICS
English version
Guidance on the relationship between EN ISO 13485: 2016
(Medical devices - Quality management systems -
Requirements for regulatory purposes) and European
Medical Devices Regulation and In Vitro Diagnostic
Medical Devices Regulation
Leitfaden zum Zusammenhang zwischen EN ISO
13485: 2016 (Medizinprodukte -
Qualitätsmanagementsysteme - Anforderungen für
regulatorische Zwecke) und den europäischen
Verordnungen über Medizinprodukte und In-vitro-
Diagnostika
This draft Technical Report is submitted to CEN members for Vote. It has been drawn up by the Technical Committee
CEN/CLC/JTC 3.
CEN and CENELEC members are the national standards bodies and national electrotechnical committees of Austria, Belgium,
Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany,
Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, 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.
Warning : This document is not a Technical Report. It is distributed for review and comments. It is subject to change without
notice and shall not be referred to as a Technical Report.
CEN-CENELEC Management Centre:
Avenue Marnix 17, B-1000 Brussels
© 2017 CEN/CENELEC All rights of exploitation in any form and by any means Ref. No. FprCEN/TR 17223:2017 E
reserved worldwide for CEN national Members and for
CENELEC Members.
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Contents Page
European Foreword . 3
Introduction . 4
1 Scope. 7
2 Normative references . 7
3 Terms and definitions . 7
4 Relationship between the European Regulations for Medical Devices and in vitro
Diagnostic Medical Devices and the clauses of EN ISO 13485 . 7
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European Foreword
This document (FprCEN/TR 17223:2017) has been prepared by Technical Committee
CEN/CLC/JTC 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 Vote on TR.
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Introduction
This Technical Report has been prepared to provide guidance on the relationship between
EN ISO 13485:2016 (Medical devices – Quality management systems – Requirements for regulatory
purposes) and the requirements in the European Regulations on Medical Devices (MDR)- Regulation
(EU) 2017/745 - and in vitro Diagnostic Medical Devices (IVDR) -Regulation (EU) 2017/746.
EN ISO 13485describes a quality management system that is applicable to medical devices and is
intended for regulatory purposes. The European Regulations for medical devices and EN ISO 13485
present holistic requirements for systematic application of a process approach to quality
management into which an organization can incorporate regulatory requirements that are
applicable to its activities. As the requirements are integrated and build on each other, all the
requirements applicable to the organizations’ activities and the applicable regulatory requirements
need to be applied. It is not intended that requirements are implemented in isolation from the
complete system. While this Technical Report describes the interrelationship of individual
paragraphs, or parts of a paragraph, of the Regulations with particular subclauses of EN ISO 13485,
this is not intended to imply that these subclauses can be implemented in the absence of the entire
quality management system described in the standard.
This Technical Report focuses on the general obligations of the manufacturer (Article 10) and the
conformity assessment requirements (Annexes IX and XI) of the European Regulations for Medical
Devices and in vitro Diagnostic Medical Devices. Compliance with all the normative clauses in
EN ISO 13485 will ensure that a process is in place to address quality management system aspects
related to medical devices, which are included in Article 10 and Annexes IX and XI of the
Regulations.
Generally, it is not meaningful to link individual clauses of EN ISO 13485 to specific general safety
and performance requirements (Annex I). The General Requirements in Chapter 1 of Annex 1,
however, relate to the application of risk and the requirements for the manufacturer to implement
a risk management system. As the general obligation of the manufacturer in Article 10 requires the
implementation of a risk management system and EN ISO 13485 requires processes for risk
management in product realization, the relationships between Chapter 1 of the general safety and
performance requirements are included in this Technical Report. Specific details of a risk
management system for medical devices are provided in EN ISO 14971.
The scope of EN ISO 13485 indicates that the standard can be applied by:
— organizations involved in one or more stages of the life-cycle, including design and
development, production, storage and distribution, installation, or servicing of a medical device
and design and development or provision of associated activities (e.g. technical support), and
— suppliers or external parties that provide product, including quality management system-
related services, to such organizations.
As such, EN ISO 13485 may be applied by other economic operators in the supply chain such as
authorized representatives, importers, distributors or assemblers of systems or procedure packs.
Consequently, EN ISO 13485 can also support meeting the obligations for quality management
systems for authorized representatives (Article 11), Importers (Article 13), Distributors (Article
14) or assemblers of systems or procedure packs (MDR Article 22).
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However, because this is an adoption of an international standard, intended to be applicable in
jurisdictions all over the world, it is not the primary goal of the standard to cover exactly the
European quality management system requirements. Therefore, 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 feed the
quality management system requirements in the applicable European Regulation into the processes
provided by EN ISO 13485.
For example, Article 15 of the European Regulations define specific requirements for a position of
‘person responsible for regulatory compliance’. While this position is not explicitly mentioned in
EN ISO 13485, it constitutes a regulatory requirement that would need to be incorporated into the
quality management system of an organization seeking to comply with the Regulations. Once
incorporated into the quality management system, related requirements, for example for
competence, definition of responsibilities and interrelationships, would apply to this position.
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.
Explanation on the relationship between the requirements of EN ISO 13485 and:
— European Regulations on Medical Devices (Regulation (EU) 2017/745) is provided in this
Technical Report in Table 1; and,
— European Regulations on in vitro Diagnostic Medical Devices (Regulation (EU) 2017/746) is
provided in this Technical Report in Table 2.
NOTE When a requirement does not appear in Table 1 or Table 2, it means that it is not addressed by
EN ISO 13485:2016.
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.
Article 8 of the European Regulations (Use of harmonized standards), indicates that system or
process requirements to be fulfilled by economic operators, such as requirements for quality
management systems, are to be presumed to be fulfilled if the system or process is in conformance
with a relevant harmonized standard. A standard is given the status of being harmonized by
publication of a reference in the Official Journal of the European Union under European Regulations
for Medical Devices and in vitro Diagnostic Medical Devices. For a harmonized standard,
presumption of conformity with the identified requirements of these Regulations is provided by
compliance with the normative clauses given in the table or tables in the Annex Z of a standard,
within the limits of the scope of the standard, once that standard has been implemented as a
national standard in at least one Member State. The Annex Z explains to which requirements, under
which conditions and to what extent, presumption of conformity can be claimed. Inclusion of a
standard the Official Journal of the European Union and the preparation, agreement and publication
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of an Annex Z requires a mandate being given to a European Standards Body by the European
Commission.
In advance of such a mandate, this Technical Report has been prepared to provide guidance to
manufacturers and conformity assessment bodies on the relationship between EN ISO 13485:2016
and the European Regulations for Medical Devices and in vitro Diagnostic Medical Devices. This
Technical Report does not imply that compliance with EN ISO 13485 provides a presumption of
conformity with the requirements of the European Regulations for Medical Devices or in vitro
Diagnostic Medical Devices.
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1 Scope
This Technical Report provides guidance on the relationship between EN ISO 13485:2016, Medical
devices – Quality management systems – Requirements for regulatory purposes and the requirements
in EU Regulation 2017/745 on Medical Devices and EU Regulation 2017/746 on in vitro Diagnostic
Medical Devices.
2 Normative references
The following referenced document is indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the
referenced document (including any amendments) applies.
EN ISO 13485:2016, Medical devices - Quality management systems - Requirements for regulatory
purposes (ISO 13485:2016)
3 Terms and definitions
For the purposes of this Technical Report, the terms and definitions in EN ISO 13485 apply.
4 Relationship between the European Regulations for Medical Devices and in
vitro Diagnostic Medical Devices and the clauses of EN ISO 13485
Table 1 shows the relationship between the clauses of EN ISO 13485 and the requirements of the
European Regulations on Medical Devices (Regulation (EU) 2017/745), together with commentary
on the extent to which the requirements of the standard cover the specific details in the Regulation.
Table 2 shows the relationship between the clauses of EN ISO 13485 and the requirements of the
European Regulations on in vitro Diagnostic Medical Devices (Regulation (EU) 2017/746), together
with commentary on the extent to which the requirements of the standard cover the specific details
in the Regulation.
Following the content of this Technical Report does not infer compliance with the specific quality
management system requirements of the European Regulations; it serves as tool for understanding
the links and connection between EN ISO 13485 and the European Regulations.
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Table 1 — The relationship between the clauses of EN ISO 13485 and the requirements of the European Regulations on Medical
Devices (EU Regulation 2017/745) Article 10, Annex 1 Chapter 1, Annex IX and Annex XI
MDR Article MDR Article 10 text MDR Annex MDR Annex text ISO 13485 Comments
10 reference reference reference
1. When placing their devices 4.1, 7.1, 7.3, Covered. EN ISO 13485
on the market or putting 7.5 includes requirements for the
them into service, QMS, design and development
manufacturers shall ensure and manufacturing that
that they have been require incorporation of
designed and manufactured regulatory requirements into
in accordance with the the quality management
requirements of this system.
Regulation.
Annex I, Devices shall achieve the performance Partially covered.
Chapter 1, intended by their manufacturer and EN ISO 13485 includes
shall be designed and manufactured in requirements to apply risk
1.
such a way that, during normal management in product
conditions of use, they are suitable for realization. The detail of the
their intended purpose. They shall be specific requirements of
safe and effective and shall not Annex 1, Chapter 1 of the
compromise the clinical condition or Regulation is not stated
the safety of patients, or the safety and explicitly.
health of users or, where applicable,
EN ISO 14971:2012 Medical
other persons, provided that any risks
devices - Application of Risk
which may be associated with their use
Management is referenced in a
constitute acceptable risks when
NOTE and listed in the
weighed against the benefits to the
Bibliography of EN ISO 13485.
patient and are compatible with a high
level of protection of health and safety,
taking into account the generally
acknowledged state of the art.
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MDR Article MDR Article 10 text MDR Annex MDR Annex text ISO 13485 Comments
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2. Manufacturers shall 7.1 Partially covered.
establish, document, EN ISO 13485 includes
implement and maintain a requirements to risk
system for risk management in product
management as described realization. The detail of the
in Section 3 of Annex I. specific requirements of
Annex 1, Section 3 of the
Regulation is not stated
explicitly.
Annex I, The requirement in this Annex to Not covered. EN ISO 13485
Chapter 1, 2. reduce risks as far as possible means includes requirements to
the reduction of risks as far as possible apply a risk-based approach to
without adversely affecting the the quality management
benefit-risk ratio. system and apply risk
management in product
realization. The detail of the
specific requirements of
Annex 1, Section 3 of the
Regulation is not stated
explicitly.
EN ISO 14971:2012 Medical
devices - Application of Risk
Management is referenced in a
NOTE and listed in the
Bibliography of EN ISO 13485.
Annex I Manufacturers shall establish, 7.1 Partially covered.
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Chapter I, 3 implement, document and maintain a EN ISO 13485 includes
risk management system. requirements to risk
management in product
realization. The detail of the
specific requirements of
Annex 1, Section 3 of the
Regulation is not stated
explicitly.
Risk management shall be understood 4.1.2, 7.1 Partially covered.
as a continuous iterative process EN ISO 13485 includes
throughout the entire lifecycle of a requirements to apply risk
device, requiring regular systematic management in product
updating. In carrying out risk realization. The detail of the
management manufacturers shall: specific requirements of
Annex 1 of the Regulation is
not stated explicitly.
EN ISO 14971:2012 Medical
devices - Application of Risk
Management is referenced in a
NOTE and listed in the
Bibliography of EN ISO 13485.
(a) establish and document a risk Not covered
management plan for each device;
(b) identify and analyse the known
and foreseeable hazards associated
with each device;
(c) estimate and evaluate the risks
associated with, and occurring
during, the intended use and
during reasonably foreseeable
misuse;
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(d) eliminate or control the risks
referred to in point (c) in
accordance with the requirements
of Section 4;
(e) evaluate the impact of information 8.2.1, Partially covered.
from the production phase and, in EN ISO 13485 requires a
particular, from the post-market document procedure to
surveillance system, on hazards and feedback information from the
the frequency of occurrence thereof, on production and post-product
estimates of their associated risks, as phase into the risk
well as on the overall risk, benefit-risk management system.
ratio and risk acceptability;
(f) based on the evaluation of the Not covered
impact of the information referred to
in point (e), if necessary amend control
measures in line with the
requirements of Section 4.
Annex I Risk control measures adopted by Not covered
Chapter I, 4. manufacturers for the design and
manufacture of the devices shall
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conform to safety principles, taking
account of the generally acknowledged
state of the art. To reduce risks,
Manufacturers shall manage risks so
that the residual risk associated with
each hazard as well as the overall
residual risk is judged acceptable.
In selecting the most appropriate
solutions, manufacturers shall, in the
following order of priority:
(a) eliminate or reduce risks as far as
possible through safe design and
manufacture;
(b) where appropriate, take adequate
protection measures, including
alarms if necessary, in relation to
risks that cannot be eliminated;
and
(c) provide information for safety 7.2.1b), d), Partially covered.
(warnings/precautions/contra- 7.2.2d), EN ISO 13485 requires the
indications) and, where appropriate, 7.3.4d) identification and provision of
training to users. user training and information
necessary for safe use.
Manufacturers shall inform users of Not covered
any residual risks.
Annex I In eliminating or reducing risks related 7.3.3a) Partially covered.
Chapter I, 5. to use error, the manufacturer shall: EN ISO 13485 identifies
usability as a specific design
(a) reduce as far as possible the risks
and development input.
related to the ergonomic features of
Design and development
the device and the environment in
inputs link directly to design
which the device is intended to be used
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(design for patient safety), and and development outputs and
requirements for verification
and validation.
(b) give consideration to the technical 7.2.1b), Partially covered.
knowledge, experience, education, 7.2.2d) EN ISO 13485 requires the
training and use environment, where identification and provision of
applicable, and the medical and user training.
physical conditions of intended users
(design for lay, professional, disabled
or other users).
Annex 1, The characteristics and performance of 4.2.4, 4.2.5, Partially covered.
Chapter I, 6. a device shall not be adversely affected 7.2.1, 7.3.6, EN ISO 13485 requires the
to such a degree that the health or 7.3.7, definition of the lifetime of the
safety of the patient or the user and, 7.5.11 medical device and
where applicable, of other persons are identification of delivery and
compromised during the lifetime of the post-delivery activities
device, as indicated by the necessary for the intended
manufacturer, when the device is use.
subjected to the stresses which can
occur during normal conditions of use
and has been properly maintained in
accordance with the manufacturer's
instructions.
Annex 1, Devices shall be designed, 4.2.3.c, Partially covered.
Chapter I, 7. manufactured and packaged in such a 7.5.11 EN ISO 13485 requires
way that their characteristics and protection during processing,
performance during their intended use storage, handling and
are not adversely affected during distribution.
transport and storage, for example,
through fluctuations of temperature
and humidity, taking account of the
instructions and information provided
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by the manufacturer.
Annex 1, All known and foreseeable risks, and Not covered.
Chapter I, 8 any undesirable side-effects, shall be
minimized and be acceptable when
weighed against the evaluated benefits
to the patient and/or user arising from
the achieved performance of the device
during normal conditions of use.
Annex 1, For the devices referred to in Not covered.
Chapter I, 9. Annex XVI [Products without an
intended medical purpose], the general
safety requirements set out in Sections
1 and 8 shall be understood to mean
that the device, when used under the
conditions and for the purposes
intended, does not present a risk at all
or presents a risk that is no more than
the maximum acceptable risk related
to the product's use which is
consistent with a high level of
protection for the safety and health of
persons.
3. MDR Manufacturers shall 7.3.7 Partially covered.
conduct a clinical evaluation EN ISO 13485 requires clinical
in accordance with the evaluation in accordance with
requirements set out in applicable regulatory
Article 61 and Annex XIV, requirements. The details
including a PMCF. contained in Article 61 or
Annex XIV are not provided
explicitly.
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4. MDR Manufacturers of devices 4.2.3 Partly covered. EN ISO 13485
other than custom-made requires that the quality
devices shall draw up and management system includes
keep up to date technical one or more files either
documentation for those containing or referencing
devices. The technical documents generated to
documentation shall be demonstrate compliance with
such as to allow the applicable regulatory
conformity of the device requirements. A summary of
with the requirements of the types of documents is
this Regulation to be provided. All the detail in
assessed. The technical Annexes II and III is not
provided explicitly.
documentation shall include
the elements set out in
Annexes II and III.
Annex XI, the technical documentation referred
Part A, 6.1, to in Annexes II and III for the types
bullet 2. approved,
Annex XI,
Part B, 12,
Paragraph 2
The Commission is Not applicable to
empowered to adopt EN ISO 13485. Pertinent to
delegated acts in European Commission.
accordance with Article 115
amending, in the light of
technical progress, the
Annexes II and III.
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5. Manufacturers of custom- 4.2.3 EN ISO 13485 requires that
made devices shall draw up, the quality management
keep up to date and keep system includes one
available for competent
or more files either containing
authorities, documentation
or referencing documents
in accordance with Section
generated to demonstrate
2 of Annex XIII.
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. Where compliance with the Not covered. Preparation of
applicable requirements the EU declaration of
has been demonstrated conformity and affixing the CE
following the applicable mark is not covered in
conformity assessment EN ISO 13485.
procedure, manufacturers
of devices, other than
custom-made or
investigational devices,
shall draw up an EU
declaration of conformity in
accordance with Article 19,
and affix the CE marking of
conformity in accordance
with Article 20.
Annex XI, When the manufacturer fulfils the Not covered. Preparation of
Part A, 5 obligations laid down in [Annex XI] the EU declaration of
Section 4, it shall draw up and keep an conformity and affixing the CE
EU declaration of conformity in mark is not covered in
accordance with Article 19 and EN ISO 13485.
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Annex IV for the device covered by the
conformity assessment procedure. By
issuing an EU declaration of
conformity, the manufacturer shall be
deemed to ensure and to declare that
the device concerned conforms to the
type described in the EU type-
examination certificate and meets the
requirements of this Regulation which
apply to the device.
7. Manufacturers shall comply 7.5.8 Partially covered.
with the obligations relating EN ISO 13485 includes a
to the UDI system referred requirement to control the
to in Article 27 and with the UDI under the quality
registration obligations management system. The
referred to in Articles 29 detail of the system prescribed
and 31. in the Article 27 and with the
registration obligations
referred to in Articles 29 and
31 are not provided explicitly
8. Manufacturers shall keep 4.2.4, 4.2.5, Partially covered.
the technical 7.2.3 EN ISO 13485 requires the
documentation, the EU retention of documents,
declaration of conformity including records, for at least
and, if applicable, a copy of the period specified by
any relevant certificate, applicable
including any amendments
regulatory requirements. The
and supplements, iss
...
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