EU: Notified Bodies resources problems

The issue of notified bodies being under-resourced is known among the industry. The last survey of the Association of British Healthcare Industries shows clearly the concerns of the manufacturers in the shortcoming of the notified bodies. The outcome of the ABHI survey was that 91% of respondents said that their applications had not been compromised due to the lack of notified body capacity; 50% of respondents said their certificate renewal was delayed by their notified body; and 32% stated that their notified body missed or seriously postponed a scheduled audit or product assessment.

In TEAM-NB’s, the European Association for Medical devices of Notified Bodies, view, there is a number of reasons for the delays and inability of notified bodies to conduct their audits in a timely manner, as highlighted in the survey. These include, among others, the new recommendations and requirements for notified bodies, including the introduction of unannounced audits. Additionally, some of the notified bodies didn’t pass the mandatory re-designation audits which means they are no longer accredited for the certification.

According to the Team-NB, the lack of resources is well known to the European Commission and the competent authorities and is expected to be a topic in the current discussions in Brussel.