In last month’s blog, we covered the European Council’s (“EC”) amendment which extends the transition deadlines for the certification of medical devices under the Medical Device Regulation MDR 2017/745 (“EU MDR”), as well as the EC’s approval of the elimination of the sell-off dates under EU MDR and the In Vitro Diagnostics Medical Devices Regulation 2017/746 (“IVDR”). Since that time, the EC published a Q&A document in March 2023 addressing the practical aspects related to these changes.
The Q&A aims to address the objectives of the amendment “with a view to making best use of the additional time provided by the extension of the MDR transitional period.” The document is comprised of 18 questions and answers divided into five main parts as follows:
Part A – Scope of the Extension of the MDR Transitional Period
Part B – Evidence of Extended Transitional Period
Part C – Conditions to be Fulfilled to Benefit from the Extended MDR Transition Period
Part D – Appropriate Surveillance to be Performed by Notified Bodies
Part E – Deletion of the “Sell-Off” Date
If you are interested, we have attached the link to the full Q&A document below. Please reach out to us if you need assistance implementing these regulations, we are here to help!
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