EC Delegating Regulations enacted to address Notified Body capacity challenges

European Regulators Move to Increase Notified Body Capacity

Two Delegated Regulations from the European Commission will decrease frequency of Notified Body re-assessments under MDR, IVDR

March 9, 2023

By Annette Van Raamsdonk

The European Commission (EC) has taken new measures to relieve some of the pressure on Notified Bodies and free up capacity to perform medical device and in vitro diagnostic (IVD) conformity assessments. Notified Bodies are assessed and monitored by Competent Authorities and the EC according to Articles 35-50 of the Medical Devices Regulation (MDR), and Articles 31-46 of the In Vitro Diagnostic Medical Devices Regulation (IVDR). Every three years a complete re-assessment of the Notified Body is required, taking a significant amount of time for all parties involved.

In December 2022, two Commission Delegated Regulations were adopted, amending the MDR and IVDR requirements regarding the frequency of complete re-assessments of Notified Bodies. These amendments are intended to change the timing of the first complete re-assessment of a Notified Body after notification from three to five years, and to establish the frequency of subsequent complete re-assessments for every five years.

With their publication in the Official Journal of the European Union (OJEU), these delegated acts haven taken into effect as of March 8, 2023:

Commission Delegated Regulation (EU) 2023/502 of 1 December 2022 amending Regulation (EU) 2017/745 of the European Parliament and of the Council as regards the frequency of complete re-assessments of Notified Bodies
Commission Delegated Regulation (EU) 2023/503 of 1 December 2022 amending Regulation (EU) 2017/746 of the European Parliament and of the Council as regards the frequency of complete re-assessments of Notified Bodies

According to the EC, “This will allow the Member States’ Designating Authorities to focus on the assessment of new applications for designation as notified body, and notified bodies to process a high number of certifications during the transitional periods, in line with the efforts we are making to improve the effective implementation of the Regulations.”

Let’s hope this will indeed lead to more capacity!

Additional European MDR and IVDR resources from Emergo by UL