22.06.2023
To the attention of manufacturers, authorised representatives, economic operators and all stakeholders
Please be informed that Commission 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 has been published.
The Regulation, together with Commission Implementing Regulation (EU) 2022/2346 of 1 December 2022 laying down common specifications in accordance with Regulation (EU) 2017/745, for the products listed in Annex XVI, will be applicable from 22 June 2023.
As a consequence of the full applicability of the Common Specifications, starting from 22 June 2023, the MDR will also become applicable to products without a proposed medical purpose that are listed in Annex XVI to the Regulation.
Please find attached the notification of the European Commission:
https://eur-lex.europa.eu/legal-content/RO/TXT/HTML/?uri=CELEX:32023R1194&qid=1687344268439