Guidance from MHRA: Regulating medical devices in the event of a no deal scenario

The Government has invested considerable time in measures to allow for business to continue as normally as possible in the event of a no-deal Brexit, although it is still the stated aim of the Government to achieve a Brexit deal with the EU.

As part of this preparation, the Medicines and Healthcare Products Regulatory Agency (MHRA) has released new information on how the regulatory environment will work if no-deal is realised.

This new set of information covers the following topics:

  • Details
  • The legislation
  • The role of the MHRA
  • Role of those manufacturing and supplying devices
  • Determining whether your product is a device
  • Classification
  • Clinical investigations and performance evaluations
  • CE marking your devices and conformity assessment
  • Labelling requirements
  • Registrations
  • Post-market surveillance and vigilance
  • Contact MHRA

Further specific detail is provided on getting your device certified, CE marking your device, and registering your device with the MHRA.

MAP strongly encourages MedTech members to read this guidance and take any necessary actions ahead of time. Find the documents here.

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Published on 27. February 2019 in News, News EU, News UK