Euro Convergence: Experts discuss MDR's early adopter pains

AMSTERDAM – While medical device makers in the European Union transition to the Medical Device Regulation (MDR), experts said that some early adopters are frustrated as new guidances continue to change what is expected of them. Notified bodies are also trying to find common and pragmatic interpretations for the regulation and guidance but must keep pace with dynamic and evolving guidance.

During a panel discussion at RAPS Euro Convergence on 11 May, experts and regulators reviewed the impact of the Medical Device Coordination Group’s (MDCG) 2022-14 position paper that was issued in August 2022 and is intended to improve notified body capacity and the availability of medical devices. The document is one of a many guidances that have been released in past few years meant to help stakeholders understand the MDR.

While the experts noted that the document offered much needed relief to notified bodies, there is still a long way to go to ensure all stakeholders are on the same page about how the MDR implementation will progress. In March, the European Council approved a measure to extend the MDR transition period amid concerns about market supply and patient access to devices. (RELATED: Council votes unanimously to extend MDR deadlines, Regulatory Focus 7 March 2023)

The panelists included Flora Giorgio, acting head of unit D3 for medical devices at the Directorate General for Health and Food Safety (DG SANTE) at the European Commission; Alexandre Jauniaux, division head at the Belgian Federal Agency of Medicines and Health products; Royth von Hahn, senior vice president of global medical health services at TÜV SÜD; and Graeme Turnbridge, senior vice president for global medical device regulatory affairs at BSI. The panel was moderated by Sabina Hoekstra-van den Bosch, vice-president of Team-NB and global director of regulatory strategy at TÜV SÜD, and Gert Bos, executive director of the Qserve Group.

Toward the end of the talk, attendee Elizabeth Gfoeller, corporate director for regulatory affairs at MED-EL, said her company was an early MDR adopter and spent a lot of resources to get their quality system ready in 2020. She said that while MDCG guidances are helpful on a theoretical level, it can be confusing as guidances change.

“There's been a lot of changes in the last two years on directions from notified bodies based on what I consider to be clear regulatory principles,” said Gfoeller. “It’s interpretation issues where we've taken interpretation, felt we had the same view, MDCG guidance comes out and it's changed, and we go back into this kind of ongoing settlement.”

“What do manufacturers do in these regulatory tricky situations,” Gfoeller asked the panelists.

Giorgio noted that as MDR is being implemented and everyone is learning as they move forward, interpreting regulations that everyone can agree on will continue to be a challenge. She said the only thing that stakeholders can do in this situation is to continue to have dialogue with each other about how to interpret the regulations to get as much assurance as possible.

“Unfortunately, you are feeling the pains of being an early adopter, which is that we're still learning about registration, we're learning about how it's implemented and what it means,” Turnbridge told Gfoeller. “You will be buffeted. Unfortunately, you're at the vanguard and that is kind of a function of the way you are from a notified body perspective.”

Turnbridge noted that there has been a deluge of guidances, which have been helpful on one hand but have added to notified bodies’ burden in other ways because they must be reviewed, and procedures need to be changed to account for them. He also said that another notified bodies can try to be as pragmatic as possible but ultimately the designating authorities are the ones who come in and dictate how guidances must be interpreted, though he predicts those differences will smooth out over time.

For now, the panelists agreed that MDCG 2022-14 is a good checklist for stakeholders to consider as they transition to MDR. While the implementation delay is a much welcome step to prevent medical device shortages, everyone needs to do their part to keep the momentum going for when the regulation does come into effect.

Giorgio said that notified bodies have been given a great deal of flexibility under MDCG 2022-14 and encouraged stakeholders to use that flexibility to their advantage.

“All these measures we’ve put in place can only work if everybody participates,” said Giorgio. "We need everybody to play their part ... or all this will be useless because we’ll put patients at risk.”