Team-NB Issues A Cry For Help And Some Slight Relief

In the spirit of MedTech Europe's repeated and vocal calls to delay the implementation of the IVDR (see previous article here), Team-NB, the trade association representing 26 leading Notified Bodies, has issued a direct message to the medical device industry.

The message is clear - as things currently stand, Notified Bodies will not be able to cope with the titanic workload as a series of waves hit:

• the MDR comes into force in May 2021;
• the IVDR comes into force in May 2022; and
• the transition period expires in May 2024.

Team-NB has published a ruthlessly concise two-page position paper which calls for solutions to be discussed between regulators, the EU Commission and trade associations to avoid the impending crisis and beaching of medical device products in the EU. The position paper charts the results of a survey of all 54 medical device Notified Bodies (disappointingly only two thirds of whom responded) which reveals that over 13,000 certificates