SIST EN ISO 13485:2016/oprA1:2019

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

Dispositifs médicaux - Systèmes de management de la qualité - Exigences à des fins

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

Dispositifs médicaux - Systèmes de management de la Medizinprodukte - Qualitätsmanagementsysteme -

qualité - Exigences à des fins réglementaires (ISO Anforderungen für regulatorische Zwecke (ISO

This draft amendment is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee

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,

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

European foreword ....................................................................................................................................................... 3

Annex ZA (informative) Relationship between this European Standard and the conformity

medical devices [OJ L 189] (as amended) aimed to be covered ..................................................... 4

Annex ZB (informative) Relationship between this European Standard and the conformity

(as amended) aimed to be covered ........................................................................................................... 9

Annex ZC (informative) Relationship between this European Standard and the conformity

devices [OJ L 331] aimed to be covered ............................................................................................... 16

requirements of Regulation (EU) 2017/745 aimed to be covered ............................................. 24

requirements of Regulation (EU) 2017/746 aimed to be covered ............................................. 39

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

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

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,

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

NOTE The way in which these referenced documents are cited in normative requirements determines the extent (in whole

The text of ISO 13485:2016 has been approved by CEN as EN ISO 13485:2016/prA1:2019 without any

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

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

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

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’,

NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with essential

NOTE 3 This Annex ZA is based on normative references according to the table of references in the European

NOTE 4 When a requirement does not appear in Tables ZA.1 or ZA.2, it means that it is not addressed by this

NOTE 5 This annex uses the term “quality system” as used in the Directive whereas this European Standard uses

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

Table ZA.1 — Correspondence between this European Standard and Annex 2 of Directive

3.1, 2 sentence, 3 indent 4.1, 5.1, 5.4, 5.5, 5.6 Covered in part. This European

3.1, 2 sentence, 4 indent 4.1, 5.1, 5.4, 5.5, 5.6 Covered in part. This European

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

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

3.2, 3 paragraph (d), 1 indent 4.2, 6.4, 7.1, 7.4 7.5 Covered provided that the quality

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

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

Table ZA.2 — Correspondence between this European Standard and Annex 5 of Directive

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

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

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

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

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

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

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’,

NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with essential

NOTE 3 This Annex ZB is based on normative references according to the table of references in the European

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

NOTE 5 This annex uses the term “quality system” as used in the Directive whereas this European Standard uses

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

Table ZB.1 — Correspondence between this European Standard and Annex II of Directive

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

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

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

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.

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

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

Table ZB.2 — Correspondence between this European Standard and Annex V of Directive