Euro Convergence: Regulators and industry seek ‘sparks’ of European change

Regulatory NewsRegulatory News
| 10 May 2021 | By Nick Paul Taylor 

The opening plenary of RAPS Euro Convergence 2021 saw regulators, competent authorities, and industry representatives highlighting pressing regulatory issues for in vitro diagnostics and combination products, among other topics.
The plenary kicked off with regulators presenting “sparks,” or hot button topics intended to trigger discussion; an industry panel was then given the chance to respond to proposals from the panel of regulators and notified body representatives.
The point, said one of the panel moderators, was to fuel an interchange of ideas that might result in lasting dialogue and change. “From a small spark a big flame may rise,” Eric Klasen, founder of Waypoint LC Consulting, said. “We hope that some ideas may be born between the stakeholders and the panel members.”
Erik Hansson, deputy head of unit medical devices and health technology assessment at DG SANTE, was among the representatives of competent authorities to propose sparks for further discussion. Hansson put forward several points for the industry panelists to respond to, including a provocative statement about the level of preparation for the In Vitro Diagnostic Regulation (IVDR) that is due to take effect in May 2022.
IVDR will require far more changes than the equivalent medical device regulation, which takes effect next month. Hansson called the regulation a “big revolution” and raised concerns about the extent to which the IVD industry is aware of the changes and preparing for them, explaining that there is “a very slow waking up” to the impact of the regulation.
“Of course, we do not expect that all IVDs will pass the stricter requirements of the new legislation. But, according to the data we are receiving, it seems that parts of the industry are not even looking into the IVDR and realizing what this means in practice. This will, of course, have consequences. It can mean that some manufacturers will not be ready in time and will have to go out of the market,” the DG SANTE representative said.
Hansson’s comments were followed by sparks shared by other regulators, including Zaïde Frias, head of the digital business transformation task force at the European Medicines Agency (EMA). Frias, in a reflection of her areas of focus at EMA, focused one of her sparks on emerging technologies.
As Frias explained, new types of combinations of medicines and medical devices “very much blur” traditional concepts and exist at the intersection of existing regulatory frameworks. Neither a drug nor a device under current definitions, the products pose a challenge for regulators. Failure to rise to that challenge could delay the progress of important products. Frias sees a need for change.
“I think it's very clear that the current state of affairs is no longer appropriate, and the approach of reviewing needs to be revised, especially I would say on borderlines [between categories],” the EMA employee said. Frias called for industry input on “flexible and creative” solutions to the issue.
Industry responds
 In turn, the panel representing industry responded to the sparks and offered their own views on the big changes underway in healthcare in Europe. While Klasen said the IVD industry is “extremely nervous for the timeline that is coming up,” Anja Wiersma, CEO and senior consultant at mi-CE Consultancy, set out reasons for optimism, including the chance for the IVD industry to leverage MDR guidance from the European Commission’s Medical Device Coordination Group (MDCG).
“I think we can learn a lot from the MDR, how the MDR is integrated. I think we can get a faster implementation then for IVDR as well,” Wiersma said. “if you look at MDR implementations and the MDCG guidances, although maybe some IVDR MDCG guidances are not there, we can use those for the IVDR. I think that's really a big spark.”
John Brennan, vice president for quality, regulatory affairs and government affairs, EMEA, at Medtronic, highlighted a potential opportunity to use MDCG more broadly as a mechanism for solving whatever problems the medtech industry and regulators encounter.
“Couldn't we have some sort of a clearing house set up through the MDCG where we can bring problems?” Brennan asked. “When the MDD started, we had the notified bodies forum. That was where the focal point was, even for regulators at the time, to actually table problems, get collectively agreed solutions and you just cleared things so fast. I think now that's the role of the MDCG.” 
RAPS Euro Convergence


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