EMERGO SUMMARY OF KEY POINTS:

• Some European Notified Bodies appear to have set early 2020 deadlines for renewals of CE Mark certifications under the Medical Devices Directive (MDD) and Active Implantable Medical Device Directive (AIMDD).
• Manufacturers may find it increasingly difficult to obtain MDD and AIMDD certifications starting in late 2019.
• These timelines should help manufacturers plan their transition strategies for Medical Devices Regulation (MDR) compliance.

Some Notified Bodies (NBs) will soon be designated to the Medical Devices Regulation (EU) 2017/745 (MDR). But how they will manage their Medical Devices Directive 93/42/EEC (MDD) and Active Implantable Medical Devices Directive 90/385/EEC (AIMDD) reviews concurrently with their MDR reviews is yet to be revealed.

Time running out for MDD, AIMD certifications

From contacts with several large NBs, Emergo understands that, depending on the timeline for designation of the NB involved, from the second quarter of 2019 onwards, it will become increasingly difficult to secure AIMDD and MDD certification. Recently Emergo received documents released by two of the larger NBs. In the first of these official documents, January 2019 is the deadline specified for new  Class III MDD and AIMDD devices requiring consultation (e.g. ancillary drug, animal tissue etc.) through August 2019 for new Class I sterile/measuring submissions. Renewal audits as part of the regular certification cycle will no longer be possible starting January 2020, which implies that all certification for the Directives will have ceased by the end of 2019.

The second document has an even steeper timeline, where signed applications for CE Mark certifications must be supplied by January 2019, with all forms and review documents sent in by March 31, 2019. There is, of course, the proviso that both of these NB sources expect MDR designation at the beginning of 2019. Other NBs may have different timelines for their cut-off dates, but Emergo expects the differences among the large NBs be limited.

Planning MDR transition strategies

This initiative helps manufacturers plan their transitions and regulatory strategies. It also illustrates that time is quickly running out for certification under the Directives, and manufacturers will soon only be able to certify under the MDR. It would, of course, be interesting to see how other NBs intend to approach these cut-off issues. Emergo recommends that manufacturers fine tune their plans with their respective NBs to ensure a smooth transition.

The first NB document also provides information about the AIMD/MDD, and asks manufacturers to indicate their plans regarding the MDR.  Let’s hope that there are sufficient NBs available to review the MDR submissions from manufacturers of Class I reusable surgical instruments,  who may not have had experience with an NB and find themselves at the end of the queue in May 2020.

Learn more about upcoming changes to European medical device regulations:

• European CE Mark consulting for medical device companies
• EU Medical Devices Regulation (MDR 2017/745) gap assessment and transition support
• EU Authorized Representative in-country representation
• Whitepaper: Preparing to change your European Notified Body