this Q&A document intends to facilitate the application of the transitional provisions set out in Commission Implementing Regulation (EU) 2022/23461 , as amended by Commission Implementing Regulation (EU) 2023/11942
. This document has not been formally endorsed by the European Commission and is without prejudice to any interpretation of the relevant provisions by the Court of Justice of the European Union or national courts. The information in this Q&A document is of a general nature and not intended to address specific circumstances of any particular case; the document does not intend to provide professional or legal advice. The information is not necessarily comprehensive nor complete. If needed, this document will be updated in order to address additional questions that may arise. Introduction Regulation (EU) 2017/745 on medical devices (MDR)3 , fully applicable from 26 May 2021, covers also products without an intended medical purpose that are listed in its Annex XVI. Common specifications addressing the application of risk management to Annex XVI products have been set out in Commission Implementing Regulation (EU) 2022/2346 (CS), which applies from 22 June 2023.
Transitional provisions set out in the MDR have been extended by Regulation (EU) 2023/6074 that also sets out conditions for benefitting from those extended transitional periods. The amended transitional provisions apply from 20 March 2023.
Considering that transitional provisions for products covered by a certificate issued by a notified body
in accordance with Council Directive 93/42/EEC (MDD)5 are set out both in the amended MDR and in the CS, Commission Implementing Regulation (EU) 2023/1194 has been adopted to align the transitional provisions set out in the CS to those set out in the amended MDR. The content of this document has been drafted considering the requirements applicable from the amended MDR and the amended CS.