Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi All,

I was wondering/hoping that someone may have taken the time to put together an IVDR equivalent to the table found in MDCG 2021-25 application of MDR requirements to 'legacy devices' and devices placed on the market prior to 26 May 21 in accordance with Directives 90/385 EEC or 93/42/EEC ?


I realise that there has been no IVDR equivalent guidance yet released for this purpose, however i feel that for the most part, the table found as the annex in 2021-25 is a useful template for the IVDR also. I was just hoping that someone had done an article to article equivalence exercise for this? And if so, are they willing to share?

Thanks in advance

Hi anon
It could be partly.
However, it has recently been published: Joint Implementation and Preparaledness Plan for
Regulation (EU) 2017/746 ON IN VITRO Diagnostic Medical Devices (IVDR),March,2022, where in chpt. . 10: Legacy Devices describes this problem.
I attach this document .

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Evangelos Tavandzis
Lead Auditor, Consultant
Praha
Czech Republic
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Original Message:
Sent: 19-Apr-2022 02:45
From: Anonymous Member
Subject: MDCG 2021-25 -IVDR equivalence

This message was posted by a user wishing to remain anonymous

Hi All,

I was wondering/hoping that someone may have taken the time to put together an IVDR equivalent to the table found in MDCG 2021-25 application of MDR requirements to 'legacy devices' and devices placed on the market prior to 26 May 21 in accordance with Directives 90/385 EEC or 93/42/EEC ?


I realise that there has been no IVDR equivalent guidance yet released for this purpose, however i feel that for the most part, the table found as the annex in 2021-25 is a useful template for the IVDR also. I was just hoping that someone had done an article to article equivalence exercise for this? And if so, are they willing to share?

Thanks in advance