Medicines and Healthcare Products Regulatory Agency

UK, European Device Industries Urge Continued Regulatory Alignment Post-Brexit

EMERGO SUMMARY OF KEY POINTS:

  • UK and European medical device and IVD industry trade groups are arguing for full MDR and IVDR implementation in Great Britain during and after Brexit negotiations.
  • The groups seek European recognition of UK Notified Bodies and Authorized Representatives as well as full access to the Eudamed database by the UK MHRA.
  • Whether Brexit negotiators adequately address the trade groups’ concerns remains an open question.

UK Regulator Launches Interactive Guide to New European Medical Device, IVD Regulations

EMERGO SUMMARY OF KEY POINTS:

  • A new interactive online guide from the UK MHRA provides high-level overviews of new European medical device and IVD regulations.
  • The new guide should prove useful for CE Mark certificate holders has they prepare for full compliance with the Medical Devices Regulation (MDR 2017/745) and In-Vitro Diagnostic Regulation (IVDR 2017/746).

UK Regulator Opens New "Office" for Innovative Medical Devices

The Medicines and Healthcare Products Regulatory Agency (MHRA), the UK medical device market regulator, has set up an “innovation office” in an effort to provide a more efficient market authorization process for manufacturers of cutting-edge products.