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Provision history · Medical Devices Regulation

Annex IX · CONFORMITY ASSESSMENT BASED ON A QUALITY MANAGEMENT SYSTEM AND ON ASSESSMENT OF TECHNICAL DOCUMENTATION

Medical Devices Regulation · 32017R0745 · every version of this act · on EUR-Lex

2 changes recorded across 2 versions, newest first.

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Amended by Regulation (EU) 2020/561 32020R0561 on EUR-Lex

Applies from: 2021-05-26

dates added to the text: 2021-05-26 · dates removed: 2020-05-26

Explanation, written by a model and checked against the cited text

In Section 5.1(h), the date by which the Commission is to provide guidance for expert panels on interpreting the criteria in point (c) was changed from 26 May 2020 to 26 May 2021.

Cited: Annex IX, v2

v1 is the previous version, v2 this one.

Text from EUR-Lex, before and after

Previous version, detected 12 August 2026 02017R0745-20170505 → this version, in force 24 April 2020 02017R0745-20200424

ANNEX IX CONFORMITY ASSESSMENT BASED ON A QUALITY MANAGEMENT SYSTEM AND ON ASSESSMENT OF TECHNICAL DOCUMENTATION CHAPTER I QUALITY MANAGEMENT SYSTEM 1. The manufacturer shall establish, document and implement a quality management system as described in Article 10(9) and maintain its effectiveness throughout the … 3,623 unchanged words … justification provided by the notified body publicly available via Eudamed. (h) The Commission, after consultation with the Member States and relevant scientific experts shall provide guidance for expert panels for consistent interpretation of the criteria in point (c) before 26 May 2020. 2021. 5.2. Procedure in the case of devices incorporating a medicinal substance (a) Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product within the meaning of point 2 of … 1,770 unchanged words … kept at the disposal of competent authorities for the period indicated in that Section in case a manufacturer, or its authorised representative, established within its territory goes bankrupt or ceases its business activity prior to the end of that period.

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Explanation, written by a model and checked against the cited text

Section 2.3 now describes the representative-sample technical documentation assessment for class IIa and IIb devices as being carried out "as specified in Section 4" instead of by reference to Sections 4.4 to 4.8, and it also inserts a new second paragraph before what was previously the second paragraph, so the cross-reference in Section 3.5 to the rationale documentation now points to the third paragraph of Section 2.3 rather than the second.

The heading of Section 3 no longer specifies that the surveillance assessment applies to class IIa, class IIb and class III devices, dropping that qualifying phrase from the title.

Section 3.5 also replaces its reference to Sections 4.4 to 4.8 with a reference to the assessment being carried out "as specified in Section 4," and Section 4.3 changes the description of who performs the examination of the application, from the notified body examining it "by using staff, employed by it," to the notified body assessing the technical documentation "using staff."

Cited: Annex IX, v1 · Annex IX, v2

v1 is the previous version, v2 this one.

Text from EUR-Lex, on this version's page