Commission Optimistic Over EU MDR Readiness While Others See A Flawed System
The European Commission is satisfied with the state of readiness of the EU MDR, but for TÜV-SÜD’s Sabina Hoekstra-van den Bosch, the system is like a well-trained athlete who is prevented from competing properly.
The European Commission has no plans to postpone the date of application of EU Medical Device Regulation any further. That was made clear by Anna Eva Ampelas of DG Sante during the second day of the MedTech Forum.
When asked at the MedTech Europe annual event whether the system was all set, she told a regulatory panel that she felt “cautiously optimistic that we are as ready as we can be,”
“I think we have achieved a lot,” she asserted, adding that “26 May is a key date – but not an end date, and not the only date.”
(26 May 2021 is the date of the MDR fully applies, but some products will be allowed to remain on the market in compliance with the current medical device directives, under certain conditions, until 26 May 2024, under the so-called “grace period.”)
The European Commission is assessing carefully what will happen when certificates benefiting from the grace period expire, Ampelas explained.
“On the commission side, we need to gather data to evaluate this and help all actors prepare,” she told the meeting, warning that if all the stakeholders leave compliance with the MDR to the last minute, “the system will be very much blocked”.
After May 2021, she said, the European Commission will continue to work very closely with notified bodies, competent authorities and manufacturers to ensure the MDR implementation is the “success it was intended to be.”
“This is a really high priority for the European Commission,” she said, “and we will very much engage in this, in the years to come as well.”
While the commission would have liked to have seen more than 20 notified bodies designated by now, she said that it was satisfied that is “quite a good figure” given their overall capacity.
‘Ready As Can Be’ But ‘Not Perfect’
The competent authority spokesperson on the panel, Thomas Wejs Møller, chair of the Competent Authorities for Medical Devices group (which is instrumental in helping direct the implementation of the MDR and IVDR) was of the opinion that the MDR is “not 100% perfect.” But, Møller, who is also director of medical devices at the Danish Medicines Agency said: “We are as ready as we can be.”
“We cannot postpone it any longer,” he asserted, adding that most competent authorities now want to work within the new regime.
Møller added that the system will continue to develop organically with time and experience and reminded delegates of the ongoing need for tools to support understanding of EU rules. Even with just a 60-page Medical Devices Directive (MDD), the medical device sector has been relying on guidance material after nearly 30 years since its full implementation date, he said.
Møller also felt optimistic about notified body capacity – he referred to some 30 more applicants in the system and predicted that capacity will grow over coming years.
One Arm Tied Behind Its Back
Speaking as the notified body representative on the panel, Sabina Hoekstra-van den Bosch of TÜV-SÜD agreed with Møller that the sector can work with the new EU medtech system but, in her view, the structure needed for the implementation of the MDR is not “in the best shape it could be” since parts remain unfinished.
Hoekstra, regulatory strategy principal at TÜV-SÜD, likened the EU system to a well-practiced athlete handicapped by having one arm tied behind their back as they start their race.
In this metaphor, she said, the arm tied to the body represents the missing parts of regulatory system, or for which temporary ad hoc solutions have been created. She was referring, in particular to the Eudamed medical device database, which will not function as intended, and as a whole, until 26 May 2022. She was also making reference to some essential guidance documents – such as relating to borderline classification, and to how notified bodies have to perform appropriate surveillance, not yet being ready on time, for example.
The notified body expert continued the analogy suggesting that the highest hurdle is at the end of race is in 2024, as has been alluded to by Ampelas.
In two to three years’ time, it is predicted that a huge swathe of applications will be received by notified bodies from companies seeking conformity assessment against the MDR for the first time.
This is because the one-year delay in the MDR date of application opened up the possibility for many companies to have their products re-certified against the directives for a maximum period up until 26 May 2024, and has meant that relatively few have already been certified against the new regulation.
In other words, notified bodies have received many applications to extend directive certificates over the last year that will now expire in 2024 when there will be a big hurdle to overcome.
But, she said, with more notified bodies available as the race nears its end along with other necessary infrastructure, such as the Eudamed database and additional guidance documents, this will effectively mean that “the athlete’s arm will be untied” making the sportsman more agile to complete it.
There was no doubt in the mind of the moderator of the session, Bassil Akra, CEO and co-owner of Quinque and moderator of the panel, that the system is handicapped. He suggested “there is still 20-30% of the system missing before we are ready to do the work.”
And the relatively small number of notified bodies is something that is on all stakeholders’ minds.
Hoekstra, though, pointed out that when it comes to notified body capacity, it is too early to know the precise bandwidth now and what will be on offer as time moves on.
There are, of course, more notified bodies on the way, she reminded attendees. But there is no transparency over who they are. For this reason, the EU notified body association, TEAM-NB, is asking its members now where they are in the designation process, she explained.
Hoekstra admitted that historic time-frames for notified body designation have been “very long” but that as time goes on and designating authorities gain experience, the process seems to be becoming “quicker and smoother”.
It is not just a matter of supply of notified body services, of course but also of their capacity and scope, and of demand. Akra reminded the audience of the high number of certificates that will need to be issued between now and 2024, as was highlighted in the recently published survey by EU notified body association, TEAM-NB.
That survey suggests, Medtech Insight notes, that somewhere between 13,500 and 16,500 certificates granted under the Medical Devices Directive and the Active Implantable Medical Devices Directive, will need to be issued again under the new MDR regime between 2021 and 2024, with the vast majority – between some 7,000 and 10,000 in 2024. (Also see “TEAM-NB Highlights Survey Figures Suggesting Massive 2024 Bulge In MDR Applications” – Medtech Insight, 15 Apr, 2021.)
Clearing House Suggestion
One delegate asked whether it may be possible to create a clearing house subgroup within the Medical Device Coordination Group (MDCG) to analyze and recommend measures to overcome the problems with limited capacity, to ensure products for special patient population continue to be available, and to address supply chain problems.
The commission’s Ampelas did not directly answer the clearing house question. But she acknowledged that the MDCG has an important role to play in implementation; she also said the commission is monitoring the situation and forecasting potential issues, including through gaining quantitative data from manufacturers.
She added that more transparency is needed regarding the rate when at which industry plans to move to the MDR and what the capacity is of notified bodies at that time to meet that demand.
“We need to find a fair balance,” she said, asserting that the commission does not want a system where there is a lack of critical devices or shortages of any products. “But, Ampelas stressed, “we would also like to have a system where devices are safe enough and comply with all the necessary provisions.”
The current article represents the views of representatives from the European Commission, a competent authority, a notified body and a consultant at the MDR readiness panel at MedTech Forum. For the reaction of someone with specific oversight from the industry point of view, and notably of SMEs, see the report on what Julia Steckeler, CEO of MedicalMountains, said at the meeting. (Also see “SMEs Buffeted About By EU MDR Delays Will Not Be Able To Financially Sustain Products” – Medtech Insight, 26 Apr, 2021.)