Joint Implementation Plan on IVDR
NB ...

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Last Updated	2 November 2021
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2021-26 Q&A on repackaging and relabelling MDR-IVDR
Article 16 MDR Article 16 IVDR ...

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Last Updated	26 October 2021
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2021-25 Application MDR to legacy and "old" devices
90/385/EEC 93/42/EEC ...

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Last Updated	26 October 2021
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2021-24 Guidance on classification of medical devices
(EU) 2017/745 MDR ...

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Last Updated	7 October 2021
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2019-6 v3 Q&A: Requirements relating to notified bodies
...

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Last Updated	7 October 2021
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2021-23 Guidance on certification activities - (MDR-IVDR)
(EU) 2017/745 (EU) 2017/746 Notified Body Distributor Importer Article 16(4) ...

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Last Updated	26 August 2021
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2021-22 Clarification on first certification - IVDR
(EU) 2017/746 Notified Body Article 48(6) ...

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Last Updated	26 August 2021
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2021-21 Guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices
98/79/EC (EU) 2017/746 ...

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Last Updated	26 August 2021
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2021-20 Instructions for generating CIV-ID for MDR Clinical Investigations
(EU) 2017/745 MDCG 2021-1 Rev.1 EUDAMED2 ...

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Last Updated	26 August 2021
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2021-19 UDI in QMS
MDR IVDR EUDAMED     ...

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Last Updated	19 July 2021
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