Q&A on the practical implementation of Implementing Regulation (EU) 2023/607 amending the transitional provisions of Regulations (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR)

The European Commission has published on the European Commission’s website a Q&A to facilitate the practical and homogeneous implementation of the transitional provisions of the MDR and IVDR amended by the Implementing Regulation (EU) 2023/607.

“The answers to the questions […] have been developed taking into account the objectives pursued by the amendment with a view to making best use of the additional time provided by the extension of the MDR transitional period.”

Thus, stakeholders can have a common understanding of the scope of the Implementing Regulation, the evidence to be provided to demonstrate that the legacy device can be placed on the market, the conditions to benefit from the new transitional provisions, or the modalities of surveillance of legacy devices by notified bodies.

DOWNLOAD THE Q&A