Lloyd’s pulls out of the EU MDR/IVDR race

13.06.2019

As we discussed in our recent article, there are currently only two notified bodies authorised to assess against the new EU Medical Device Regulations (EU MDR): TÜV SÜD and BSI UK. MedTech Europe (the medical device industry body) has identified this as a serious cause for concern, given the essential role performed by notified bodies.

Against this background, we have just been made aware of a further, unwelcome, development on the road to the EU MDR coming into full effect . We understand that Lloyd’s Register Quality Assurance (LRQA), a major notified body, has written to its customers announcing that it will cease to be a notified body in 90 days. As well as no longer providing notified body services under the current framework, LRQA will not seek approval under the EU MDR/IVDR framework.

LRQA attributes its decision to “recent market developments” – which likely includes the increased requirements for notified bodies under the new regulatory framework. As with recent reports that the sole Spanish notified body would be ceasing operations, the withdrawal of LRQA from the market is likely to compound concerns of an EU MDR approval bottleneck.

More immediately, LRQA’s current customers need to move quickly to find a replacement notified body, as it appears LRQA intends to cease operation regardless of whether or not its customers have found an alternative. This will leave some manufacturers in an extremely uncomfortable position.

Ultimately, the potential for a serious disturbance in the medical devices market remains, and announcements such as this exacerbate the risk.

Alex Denoon

Author

Zac Fargher

Author