May 26, 2020

The European Commission has published new regulations to ease designation renewals to current Medical Device Directives ahead of the Medical Devices Regulation’s (MDR) new May 2021 date of application.

The new regulation (Implementing Regulation (EU) 2020/666) amends Implementing Regulation (EU) 920/2013 pertaining to Notified Body (NB) designation renewals to the Medical Devices Directive (MDD) and Active Implantable Medical Devices Directive (AIMDD); European regulators intend the new regulation to help qualifying NBs maintain their ability to issue CE Mark certifications to medical device manufacturers under the MDD and AIMDD over the next 12 months, helping ensure adequate supplies of medical devices and equipment during the coronavirus pandemic.

Specifically, Implementing Regulation (EU) 2020/666 targets NBs whose MDD and AIMDD designations are set to expire before the MDR’s date of application (May 26, 2021). Affected NBs may forego on-site audits and assessments by their designating authorities during this timeframe, but must still undergo surveillance and monitoring by said authorities.

Designating authorities in the European Union must also inform the Commission as well as each other regarding any NB designation renewals under the amended regulation.

Bottom line: By amending Implementing Regulation (EU) 920/2013, the European Commission aims to mitigate NB capacity issues and help manufacturers of CE Marked medical devices maintain their European market access during the new 12-month transition period to MDR.

Learn more about European medical device market access at Emergo by UL:

  • European MDR preparation and compliance resource center
  • EU emergency market access consulting for medical device and IVD companies
  • Whitepaper: How to select or change your European Notified Body

Author

  • Stewart Eisenhart

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