The Domino Effect?
The last few months have not been a good time for EU Notified Bodies (NBs) and the impact on the MedTech Industry is even worse.
In what now seems to be a race to leave the Notified Body ‘pond’:
- Lloyd’s Register in the UK confirmed their withdrawal of NB services for medical devices and IVDs and also withdrew their application in The Netherlands for designation under the new medical devices and IVDs regulation.
- Next QS Zurich withdrew from the sector ahead of the full enforcement of the EU Medical Devices Regulation (MDR) on 26th May 2020. The reason they gave was that “the investment required to continue is “too high” for a small notified body”.
- UL International (UK) has announced their decision to terminate their operations as a Notified Body under the medical device directive (MDD) and is dramatically limiting their support of IVDs under the ‘old’ directive. Fortunately, they’ve partnered with the Polish Notified Body, Polskie Centrum Badan I Certyfikacji S.A. (PCBC). Via this partnership, their customers are transferring their UL CE certificates. 80% of CE certificates have already been transferred and the remainder have been transferred to another EU NB.
- In May, the Spanish Agency of Medicines and Medical Products (AEMPS) announced that they will no longer accept device applications from new clients and will stop processing new certificate applications from their existing clients as from 31 July 2019.
Understandably the industry is not convinced that the MDR will be fully enforced on 26th May 2020. The European Commissioner for Health and Food Safety, however, is not of the same opinion. They have issued reassurance that an extension to the May 2020 deadline will not be necessary. They are also predicting that about 20 NBs will obtain designation under the new MDR before the end of this year. The remaining 10 or so NBs will be designated by the May deadline.
Probably all we can say at the moment is:
“time will tell”!