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MHRA issues statement regarding EU’s transition extension timescales for legacy devices

  • Posted by: inetika
  • Category: GLOBAL NEWS

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has updated its webpage referencing the EU’s publication of Amending Regulation (EU) 2023/607 on the extension of transition times for ‘legacy devices’ under the Medical Device Regulation (MDR, 2017/745) to advise that:

“These extensions apply automatically in Northern Ireland. Certificates that have been extended will also be recognised as valid for placing CE marked devices on the GB market,” and that “We will update our registrations guidance to reflect this change.”

While awaiting the publication of specific guidance from the Agency, it is to be assumed that all aspects of the EU’s Amending Regulation will be recognised by MHRA, including those that are clarified in the Commission’s Q&A Guidance document that was published recently.