We have been closely monitoring the challenges faced by the Life Sciences sector in the lead up to the EU Medical Devices Regulation[1] (EU MDR) coming into full effect on 26 May 2020 (and the IVD Regulation[2] in May 2022 (EU IVDR)). In particular, as set out in previous articles, there is a significant shortfall between the number of medical devices that will require EU MDR certification, and the number of Notified Bodies capable of certifying them.

To further compound matters, another Notified Body has decided not to pursue designation under the EU MDR. Switzerland-based QS Zürich AG has announced its withdrawal from consideration, citing that the “investment was too high” to warrant it seeking approval.[3] It will continue to provide certification against EN ISO 13485 but will also wind up its supervision of medical devices under the Medical Devices Directive (MDD).[4] This follows last week’s announcement from Lloyd’s Register Quality Assurance that it too is no longer seeking EU MDR certification, and is ceasing to oversee its existing MDD clients.

Developments such as these heighten the anxiety of manufacturers and regulators. On the latter, a recent joint statement from the German and Irish Governments[5] expressed serious concern about the paucity of EU MDR Notified Bodies, as well as the total lack of Notified Bodies capable of certifying against the new EU IVDR. They urged the Commission and Member States to “take a step back and carry out checks on progress and readiness” against the EU MDR, as soon as possible.

These developments sit in contrast to a recent pronouncement from the European Commissioner for Health and Food Safety, Vytenis Andriukaitis, that the regulatory regime will be ready and functional in time.[6] Mr Andriukaitis currently estimates that 20 Notified Bodies will be approved by the end of 2019. Industry does not share this optimism.

It is no exaggeration to say that at present, as many Notified Bodies have pulled out of the EU MDR process as have actually been approved: two for two.[7] With less than a year to go, the likelihood of the EU MDR having a smooth landing seems more remote by the day.

[1] 2017/745.

[2] 2017/746.

[3] https://www.raps.org/news-and-articles/news-articles/2019/6/another-notified-body-bows-out-ahead-of-eu-mdr-i.

[4] 1993/42/EEC.

[5] Specifically, the delegations to the to the Employment, Social Policy, Health and Consumer Affairs Council session on 14 June 2019

[6] https://www.icij.org/investigations/implant-files/european-health-ministers-fight-to-postpone-medical-device-safety-laws/.

[7] Although, in fairness, the two approved are the largest Notified Bodies.