The current uncertainty surrounding Brexit, combined with a lack of guidance from the EU on the new Medical Devices Regulation (EU MDR) and IVD Regulation (EU IVDR), has sent the medical devices sector into a state of alarm. We have previously reported that two notified bodies (NBs) announced their withdrawal from the EU MDR approval process, adding to the mounting pressure on NBs and device manufacturers ahead of the EU MDR coming into full effect next May.
Adding to these concerns, another NB, UL UK, announced on Monday that not only it has not yet applied for EU MDR/IVDR approval, but that it will cease to operate as a NB under the outgoing Medical Devices Directive (MDD) and will be dramatically restricting its operations under IVD Directive (IVDD). UL UK decided to transfer its CE certificates to an EU-based partner organisation and stated that it did so in order to mitigate the risk of its clients losing their CE certificates in the event of a no-deal Brexit.
UL UK states that it has already transferred over 80% of its CE certificates to its Polish partner, the Notified Body Polskie Centrum Badan I Certyfikacij (PCBC). However, UL UK’s decision shines a light on the additional difficulties faced by UK NBs, in addition to those associated with preparing for the EU MDR.
Between the paucity of EU MDR-approved notified bodies, the increased certification requirements for devices and the possibility of a no-deal Brexit, the medical devices sector is on the verge of a crisis. It is likely that other notified bodies will follow in the footsteps of UL UK over the coming months. For now, we will be keeping a watchful eye out for further announcements of this kind, and for any guidance issued by the European Commission on the upcoming changes.