IVDR delays: proposal submitted for new transition periods!
The EU Commission unexpectedly published a proposal for an IVDR amendment.
Please keep in mind that this is only a proposal at the moment!
Here is the proposal md_2017-746-regulation_2021-amendment_en.pdf
"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 this Regulation requires the involvement of a notified body, may be placed on the market or put into service until the following dates:
(a) 26 May 2025 for class D devices;
(b) 26 May 2026 for class C devices;
(c) 26 May 2027 for class B devices;
(d) 26 May 2027 for class A devices placed on the market in sterile condition"
Here is the official press release: https://ec.europa.eu/commission/presscorner/detail/en/ip_21_5209