EU Authorities Consider Reviewing Products If Notified Body Shortfall Threatens Product Availability
Industry has been hammering away the message that the medtech system is heading for crisis. A fallback plan is under review as authorities share industry’s concerns. Authorities are considering reviewing some products, among other solutions.
The situation regarding the delay in the designation of notified bodies under the new EU medical devices regulations is looking so critical that some member state competent authorities have even started discussing whether they should step in and assess the conformity of some of the products themselves.
This surprising news was shared with Medtech Insight by Gert Bos, executive director and partner at QServe consultancy in the light of discussions at EU conferences last week held in Brussels – the RAPS European regulatory meeting, and Paris – MedTech Europe's MedTech Forum.
The governments that have publicly talked about an alternative solution, or a "Plan B", all indicate that this is needed, as they see notified body designations being slow, and hence a bottleneck in notified body reviews seems inevitable, Bos said.
In terms of considering doing their own conformity assessments, the regulatory authorities’ focus seems to be the IVD Regulation (IVDR), where there have only been nine applications for designation as notified bodies, compared to the 22 notified bodies that are currently active in this area under the IVDD. This is at a time when there is going to be a massive increase in the number of IVD companies needing notified body input as, under the IVDR, some 80-85% of products will need notified body involvement compared with just 10-15% now. And some of these nine may have to cease activities due to Brexit
Bos commented that about a dozen authorities are speaking among themselves to find a solution to the likely bottlenecks that lie ahead.
Medtech Insight questions, however, where the manpower and finances would be found for this at a time when available resources and expertise is short. But the very fact that the authorities are even discussing such a proposal shows that there are very deep concerns at the highest level.
Member States Listening Where Commission Seems Inflexible?
It is also an indication that the medtech industry’s biggest concerns are being heard. Desperate calls from MedTech Europe to the European Commission for some sort of delay or additional provisions to cope with the delayed setting up of the structures and documents to support the new medical device regulation seemed to have fallen on deaf ears so far.
Indeed, the Commission’s consistent message to industry has been that it needs to get on with its preparations and that there will be no further allowances.
Bos commented to Medtech Insight that the Commission has its hands tied because there is no imminent or legal way to extend the timelines.
These member state authorities, he said, are also trying to find ways via their national medical device laws, through national exemptions, on how certain medical devices could stay on the market after the transitions are over.
But, Medtech Insight notes that industry has already commented on how fragmented and challenging this would make the EU market for industry.
Manufacturers Must Prove They Are Not To Blame
Even though the new EU medtech regulatory system may feature gaps and shortfalls when it is due to fully apply – on 26 May 2020 for medical devices and 26 May 2022 for IVDs – manufacturers need to ensure that they do all they can to comply with the regulations now, so they are not the ones to blame for the delay. The hope persists that, at the point of full implementation, they may find the system becomes more forgiving than the texts of the MDR and IVDR and than the European Commission is saying.
If, once the MDR is fully applicable, companies fail to obtain a certificate for their products and moreover it is not their fault – because the notified body, or essential structures/measures from the authorities are not ready – it is more likely that new ways will be found to maintain those products on the market, Bos said.
*Bos will also be speaking in Brussels on 17 June 2019 at the week-long KNect 365 MedTech Summit on medtech regulatory issues in the EU and globally.