The European commission adopted implementing regulation (EU) 2023/1194 of 20 June 2023 amending Implementing Regulation (EU) 2022/2346 as regards the transitional provisions for certain products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 of the European Parliament and of the Council.
An amendment of the “Implementing Regulation (EU) 2022/2346 as regards the transitional provisions for certain products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745” is now published by the EU:
- If there is no need for a clinical investigation the end of the transition period set to June 22nd, 2025 should be replaced by December 31st, 2028, the deadline to sign with a notified body is replaced by January 1st
- If there is a need for a clinical investigation the end of the transition period set to June 22nd, 2028 should be pushed out to December 31st, 2029 whereas the deadline to sign with a notified body is replaced by January 1st
This Regulation shall apply from June 22nd, 2023, as well as the Implementing Regulation (EU) 2022/2346 laying down Common Specifications CS for Annex XVI products. As a consequence of the full applicability of the CS, from June 22nd, 2023, the MDR will also become applicable to products without an intended medical purpose that are listed in Annex XVI to the Regulation.
What does this mean to you?
This amended Implementing regulation (EU) 2023/1194 is of relevance for manufacturers with devices that fall within the definition of the groups of devices listed in Annex XVI that require Notified Body involvement.
Should you want to discuss this more in depth with one of our consultants, please do not hesitate to get in touch with us.
