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MDR Extension Q&A Guidance now published

  • Posted by: inetika
  • Category: GLOBAL NEWS

Further to the acceptance of the European Parliament and Council of the Commission’s recommendations for extending the transition period of MDD ‘legacy devices’ under the MDR, the Commission has published a guidance document titled ‘Extension of the MDR transitional period and removal of the ‘sell off’ periods:
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.’ A copy of the Amending Regulation can be accessed here.

The Introduction to the document states: “The answers to the questions set out below 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.”

Other information sources on the time extension: