January 25, 2023

How long are the transition periods for IVDR?

The length of the new deadlines depends on the future IVDR risk class and whether a notified body has already been involved under IVDD. Interestingly, according to the current proposal, the EU has moved the original cut-off date from May 26 to the turn of the year:

(a) 31 December 2027, for class D devices; 

(b) 31 December 2028, for class C devices; 

(c) 31 December 2029, for class B devices and for class A devices placed on the market in sterile condition.  

Class A non sterile must be under IVDR from May 2022.

To qualify for these deadlines you need to meet the minimum requirements, such as ISO 13485 or QMS, agreement with a notified body, etc.

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