Jan 15, 2020

The May 25, 2020 MDR deadline is approaching rapidly, and by now many medical device manufacturers are aware that the MDR requires the proactive collection of post-market clinical follow-up (PMCF) data.

PMCF and senior management

The compliant and cost-effective gathering of this increased level of clinical evidence data, as well as other regulatory requirements introduced by the MDR, hinges on support by senior management. The increased requirements significantly increase the workload of our RA colleagues. In addition, RA departments have to learn how to approach proactive clinical evidence collection activities. While larger companies may have the resources to spread the additional workload of this critical task to several experts in the field of clinical research, in small to medium-sized companies it has to be addressed by a smaller pool of RA personnel with limited or no previous experience in what it takes to proactively or even retrospectively collect clinical data.

Awareness of increased clinical data collection workloads

In our daily experience, unfortunately, when discussing with RA/QA personnel how to collect relevant clinical data, we have found that senior management may be insufficiently aware of the increased workload associated with the new MDR mandate to collect post-market data under the MDR. In other cases, post-market surveillance (PMS) and PMCF activities have not been adequately budgeted. Such discrepancies will negatively impact the compliance level demanded these days by European Notified Bodies, and could lead to invalidation or abrogation of the validity of a manufacturer’s CE Mark certificate under the Medical Devices Directive (MDD), with disastrous commercial consequences as well as increased frustration among RA staff.

To address the need for post-market clinical evidence, the following recommendations are appropriate:

  • Assess what kind of information is already available for the medical device. There might be more information available than expected, but it needs to be traced or “dug out” from existing sources.
  • Determine, based on this analysis, which clinical data is or might still be needed. Once your data gaps are identified, plan respective activities, and wherever possible get your Notified Body’s “buy-in” to your planned PMS and PMCF activities.
  • It is essential to assign an “adequate” budget to the planned activities. Clinical activities–be they pro- or retroactive–come with a price tag, but if adequately planned and executed, a multi-year budget can be presented successfully to the executive level.

Manufacturers should note that the better and more detailed their initial gap analyses are, the better their resulting clinical activities will be—and they will achieve more realistic cost estimates for clinical trial activities.

External support for clinical activities under MDR?

It should not be expected that RA/ QA experts can routinely address all recommended steps without some external support. The involvement of external experts, especially if in-house expertise is not available (e.g. for the gap analysis or planning of clinical activities) may significantly reduce costs, and help increase the level of compliance expected by Notified Bodies. This involvement may also help train newly hired staff intended to address the needs described above by creating fairly quickly the expertise required to deal with the steeply and acutely increased Notified Body expectations.

A full understanding in a timely fashion of what needs to be done (and to assess where help is needed) long before the MDR recertification will hit the validity of the CE Certificates is essential. Once a citation is issued for lack of compliance, it is often too late to act.

Dietmar Falke is Head of Clinical Research and Jaap Laufer is Medical Director at Emergo by UL.

Learn more about European MDR and clinical data requirements at Emergo by UL:

  • EU Medical Devices Regulation preparation and resource center
  • On-site MDR training for medical device companies
  • EU MDR gap assessment and CE Mark transition strategy
  • Whitepaper : PMS and PSUR requirements under the EU MDR