Proposal for transitional provisions for certain in vitro diagnostic medical devices under Regulation (EU) 2017/746


European Commission issued a proposal 2024/0021 (COD) for amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, information obligation in case of interruption of supply and the transitional provisions for certain IVDR.  Once approved by the council and parliament this will give more time for many IVD manufacturers to comply with the IVDR.

Devices for which the conformity assessment procedure pursuant to Directive 98/79/EC did not require the involvement of a notified body, for which a declaration of conformity was drawn up prior to 26 May 2022 in accordance with that Directive, and for which the conformity assessment procedure pursuant to (EU) 2017/746 requires the involvement of a notified body, may be placed on the market or put into service until the following dates:

  • 31 December 2027, for class D devices
  • 31 December 2028, for class C devices
  • 31 December 2029, for class B devices and for class A devices placed on the market in sterile condition.

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