Europe – Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices REV. 1

Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607
amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional
provisions for certain medical devices and in vitro diagnostic medical devices1
.
Disclaimer: This Q&A document is intended to facilitate the application of Regulation (EU) 2023/607 of the European Parliament and of the Council of 15 March 2023 amending Regulations (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR) as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices. 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…