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REGULATION (EU) 2022/112 - Updates to the In Vitro Diagnostic Medical Devices Regulation

The amendments made to the IVDR transitional provisions do not postpone the IVDR’s entry into application on 26 May 2022. This is documented under the REGULATION (EU) 2022/112 issued on 25 January 2022. However, the amendments extend the grace periods for most IVDs that were already placed on the EEA market in compliance with the IVDD. Accordingly, IVDs which are the subject of a valid CE Certificate of Conformity issued under the IVDD prior to 26 May 2022 can continue to be placed on the market or put into service until 26 May 2025. IVDs for which a Declaration of Conformity was issued under the IVDD prior to 26 May 2022 based on a self-assessment but which will be up-classed and require the involvement of a Notified Body under the IVDR for the first time, can continue to be placed on the market until the following dates:

Risk class

Deadline for placing on the market

Class D

26 May 2025

Class C

26 May 2026

Class B

26 May 2027

Class A devices placed on the market in a sterile condition

26 May 2027

Find the Regulation REGULATION (EU) 2022/112 here:


Regulation EU 2022-112
.pdf
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