IVDR 2017/746

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).

Entry into Force Milestone Reached for European Medical Device, IVD Regulations

EMERGO SUMMARY OF KEY POINTS:

  • The European Medical Device Regulations (MDR 2017/745) and In Vitro Diagnostic Regulations (IVDR 2017/746) have been entered into force as of May 26, 2017.
  • The Regulations’ entry into force is the last milestone before full implementation of the MDR in May 2020 and the IVDR in May 2022.