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MDCG 2021-25 Rev 1 : Regulation (EU) 2017/745 – application of MDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2021 in accordance with Directives 90/385/EEC or 93/42/EEC – Octobre 2021

3 Dec 2021 |

Theme Interpretation of the transitional provisions for DM certified under the Directives Target Audience Manufacturers, Notified Bodies Products concerned MD certified under the directives (IVD excluded) Documents mentioned MDR (EU) 2017/745 MDR – Article 120 Blue...

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MDCG 2021-23 : Guidance for notified bodies, distributors and importers on certification activities in accordance with Article (16)4 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 – August 2021

7 Sep 2021 | ,

Theme Certificates Target Audience Notified bodies, distributors and importers Products concerned MD & IVD Documents mentioned MDR (EU) 2017/745 IVDR (EU) 2017/746   This guide is intended to assist NB in carrying out certification activities in accordance...

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MDCG 2021-22 Rev. 1 : Clarification on “first certification for that type of device” and corresponding procedures to be followed by notified bodies, in context of the consultation of the expert panel referred to in Article 48(6) of Regulation (EU) 2017/746 – August 2021

7 Sep 2021 | ,

Theme Expert panel consultation referred to in article 48(6) of Regulation (EU) 2017/746 Target Audience Notified bodies - Manufacturers Products concerned IVD Documents mentioned IVDR (EU) 2017/746 Directive 98/79/EC   This MDCG guide sets out criteria to be...

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MDCG 2021-17 : Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/745 (MDR) – July 2021 MDCG 2021-18 : Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/746 (IVDR) – July 2021

7 Sep 2021 | ,

Theme Designation as notified bodies Target Audience Conformity assessment bodies Products concerned MD & IVD Documents mentioned MDR (EU) 2017/745 IVDR (EU) 2017/746 Commission implementing regulation (EU) 2017/2185   These MDCG guides (17 and 18) are the...

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MDCG 2021-15 : Application form to be submitted by a conformity assessment body when applying for designation as notified body under the medical devices regulation (MDR) – July 2021 MDCG 2021-16 : Application form to be submitted by a conformity assessment body when applying for designation as notified body under the in vitro diagnostic devices regulation (IVDR) – July 2021

3 Sep 2021 | ,

Theme Designation as notified body Target Audience Conformity assessment bodies Products concerned MD & IVD Documents mentioned MDR (EU) 2017/745 IVDR (EU) 2017/746 These MDCG guides (15 & 16) correspond to the forms to be completed by conformity assessment...

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