Europe – European Commissioners loosen some MDD, AIMDD designation renewal requirements for Notified Bodies

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…