More work, fewer resources and broad uncertainty put pressure on notified bodies

| by Deirdre Harrington

When the Medical Devices Regulation (MDR) came into force, many notified bodies decided not to pursue accreditation. Others are still waiting to get approval. That has meant far fewer notified bodies to perform assessments and more experienced medical device reviewers retiring or moving to industry.

The challenge for notified bodies is compounded by the fact that they not only are reviewing products under the MDR, but they must also still manage products under the Medical Devices Directive (MDD). This has put enormous strain on remaining notified bodies – now fewer than 40 compared with 96 under the MDD.

It must be remembered that the MDR is new to notified bodies as well as to manufacturers. When it first came out, each notified body had a different interpretation of the regulation, further adding to the complexity. There was no coherent agreement between all the notified bodies about how to address certain issues or items that they found in technical files.

Collaboration through Team NB

Recognising the challenge, the notified bodies came together under the banner of Team NB to ensure some coherence with interpretations of the MDR and to address inconsistencies. Team NB meets regularly ensuring its members receive the most current information on regulatory development.

Team NB, which has 33 members representing 17 countries, attends commission and working group meetings and feeds information back to its members.

While this provides helpful support to notified bodies, the challenges facing them are still immense. MDR requires that manufacturers provide clinical and post-marketing data, and these requirements are often as new to the notified bodies as they are to the manufacturers.

Finding MDR experts

As a result, notified bodies have had to look for new expert resources to support these requirements, and that has not been easy, given how few people have this type of experience in the medical devices field. Notified bodies are therefore competing for the same resources as the manufacturers and even the regulators – expertise that is already scarce.

In time, as the MDR becomes more familiar, the talent pool will likely expand and resources will become less scarce.

One move that has certainly helped in this regard is  the vote by the European Parliament to extend the MDR transition periods. This gives both the notified bodies and the manufacturers a reprieve and time to become more familiar with the new requirements. However, the capacity of notified bodies remains an issue, and while there have been efforts to work through more MDR applications, the pressure remains.

“Team NB meets regularly ensuring its members receive the most current information on regulatory development.”