EMERGO BY UL SUMMARY OF KEY POINTS:

  • European MDR clinical data requirements may impact up-classified medical devices as well as recertification of some devices.
  • Manufacturers with CE Marked devices should be preparing post-market clinical follow-up (PMCF) studies now in order to comply with MDR requirements in 2020.
  • Meeting the MDR’s PMCF requirements may impact some manufactures’ budgets in unforeseen ways.

The uncertainties about a “No-Deal Brexit” may distract many manufacturers from preparing adequately for the new requirements associated with the new Medical Device Regulation (MDR), including clinical data rules.

The need to provide clinical data for a significantly increased number of medical devices, whether the data is collected on a predicate device, during pre-CE clinical trials or during Post Market Clinical Follow-up (PMCF) studies, will present a big challenge for most manufactures.

It is safe to say that the number of CE Mark certifications based solely on clinical literature comparisons to equivalent devices will be reduced considerably, as it cannot be expected that manufactures will gain full access to clinical data that their competitors collected on predicate devices. Other devices might be up-classified, potentially requiring clinical data for re-certification.

In any case, when it comes to re-certification manufacturers will need to provide PMCF study data (from completed or ongoing studies), or at least PMCF study outlines for many devices currently on the market, especially in cases where devices whose safety or performance characteristics must be assessed over longer time periods are concerned.

MDR transition period ends soon

The MDR came into force on May 25th, 2017 and the Regulation’s three-year transition period will end in spring (May 24th), 2020. We expect that starting towards the end of 2019, an increasing number of devices will not be able to obtain certification or re-certification under the Medical Devices Directive (MDD) anymore. By May 25th, 2020, all new and re- certifications will be governed by the MDR.

Notified Bodies (NB) will likely enforce the requirements for clinical data, so manufacturers should not wait with the initiation of their PMCF or Pro-Active PMS activities until their NBs request clinical data. Not providing requested clinical data may ultimately result in the loss of CE Mark certification.

How are manufactures addressing increased requirements for clinical data?

Some manufactures are in the process of evaluating their portfolios to identify which devices will be subject to additional clinical data rules. Unfortunately, they may decide to discontinue  their - less-profitable devices  once they realize that costly additional clinical data are needed for re-certification, even if those products have been on the market for decades without problems (“legacy products”).

For their remaining medical devices that may need additional data, these manufacturers are in the process of preparing and implementing PMCF plans, including PMCF studies.

However, many manufacturers may not be prepared to conduct PMCF studies. They do not (yet) plan PMCF studies even though it is foreseeable that they will need additional clinical data for re-certification of their devices. More importantly, these manufacturers may not have included the costs of conducting PMCF studies in their budget planning.

Other manufacturers underestimate the efforts needed to conduct PMCF studies, and do not assign personnel experienced in study planning and conduct. Once started, these studies quite often will need additional support resulting in increased, unbudgeted costs.

Conclusion: Post-market clinical planning should start now

If they have not yet started, manufacturers are advised to start planning their needed post-market activities now. Furthermore, firms should ensure to involve internal and/or external experts who are experienced in the early study planning period. -Proper planning is the first step for a successful post-market clinical study.

Dietmar Falke is Head of CRO at Emergo Clinical BV.

Related European medical device clinical regulatory resources from Emergo by UL:

  • European CE Marking strategy for medical device companies
  • European PMCF study support for medical devices
  • EU MDR gap assessment and transition consulting
  • Medical device clinical trial management and monitoring support
  • Whitepaper: European PMCF studies

Author

  • Dietmar Falke