Notified Body

Greater Oversight of Notified Bodies in Europe gives Manufacturers Hope … maybe

In the wake of former Commissioner John Dalli’s call last year for tighter EU regulatory controls over the medtech industry following the PIP breast implant debacle, twelve notified bodies across Europe have been subject to new-style joint audits, in which a team from the competent authority and EU Commission officials share the duties. Five notified bodies have received sanctions, which rise to the level of public reporting. Partial suspensions, for example, would not have been made public, so it could be worse than meets the eye. Only the withdrawal and suspension sanctions were reported. One notified body in each of the UK, Lithuania, Turkey and Slovakia have had their notified body designation withdrawn and another in Turkey has had its designation suspended.

This is bad news and good news. Certainly, withdrawal of a notified body’s designation has the greatest impact on manufacturers since all certificates issued by that notified body for products impacted by the withdrawal are invalidated making the related CE marks themselves invalid. Certificates issued to manuacturers by a notified body receiving a suspension remain valid but cannot be changed or renewed during the suspension in most cases. That is the bad news.

The good news may be that political decision makers could consider these sanctions as enough punishment to deliver marked improvement in the processes of notified bodies, thereby relaxing the political will to vote for the strictest and most controversial regulatory option on the table in the context of the proposed new Medical Device Regulation; namely, the option in which the European Medicines Agency becomes involved in the designation and oversight of so-called “special” notified bodies (SNBs) accredited to test those devices considered to be particularly high risk.

We will have to wait some time yet to see if the good news becomes reality.