Europe – Increased requirements for clinical evidence under the new Medical Devices Regulation (MDR)

  • European MDR clinical data requirements may result in up-classification or recertification of some medical 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.