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BSI’s Gary Slack Explains Why MDR Take-Up Is So Slow
There is not much demand currently for testing against the EU’s Medical Devices Regulation (MDR). But demand for certificate renewal under the current medical device directives is very high. What does all this mean as the EU attempts to introduce tighter requirements for medical devices?
Despite being designated under the MDR in January this year, BSI, one of Europe’s largest medtech notified bodies, has only issued one certificate under the MDR so far. It does not expect to issue more than ten by the year end.
The vast majority of EU medtech companies are instead seeking renewal under the current medical device directives, Gary Slack, senior vice-president of global medical devices at BSI, revealed to Medtech Insight during a recent interview. This is where the capacity issue is at present.
This is an interesting snapshot of how the medtech industry is managing its regulatory strategies considering the lack of readiness of the new EU medtech regulatory system, particularly so because BSI has a large proportion of clients who manufacture high-risk medical devices.
It raises many questions: Is the lack of readiness of the structures underpinning the MDR causing this approach? Is this evidence that the system is more prepared for managing MDR demand than industry has been suggesting? Has the European Commission managed to get the right balance of products that can benefit from the renewal program, so that there will be enough resources for notified bodies to assess in time those companies who cannot benefit from the extension?
And is this really what the European Commission, European Parliament and Council of the EU had in mind when they argued for an urgent update of the EU’s medical device regulations?
Whatever the answers, it looks as if the industry prefers to stick with the option of certainty where it can.
In a recent interview, the first of three on BSI’s position in the EU notified body market, Medtech Insight asked Slack to explain more about EU medtech regulatory trends now we are some six months from the date of full application of the MDR, and about how BSI is managing them.
Medtech Insight: How many conformity assessment certificates have you issued under the MDR so far? How many do you hope to issue by the year end? How many by 26 May 2020?
Gary Slack: The real drive for certification under the MDR has not got off the ground yet. We have only issued one, so far, for Novartis’ Concept 1 inhaler, as you have publicized. But several others are close to completion. The only other certificate that has been issued under the MDR to my knowledge is for Biotronik’s Renamic programmer software, which was audited by TÜV-SÜD.
Demand is still quite low, so we are not expecting to issue more than ten MDR certificates by the end of 2019. It takes time; conformity assessment is a long process and takes on average six to nine months. We would anticipate issuing many more than 100 certificates before May 2020.I would be very surprised if other notified bodies are seeing much difference. There are only seven designations involving five organizations in total, as BSI and DEKRA have been designated against both [MDR and IVDR] regulations. If there is overdemand in system right now, this is because very few notified bodies have been designated so far. Some notified bodies have only just been designated are unlikely to have started work yet under the MDR. You won’t see many MDR CE markings this year, for sure.
Slack: We were first EU notified body to be designated. We were designated in January 2019, only 16 months before MDR date of application. Despite this, the European Commission would not allow notified bodies to assess any products prior to our designation, or sign contracts with manufacturers to do so.
So, we couldn’t start testing against the MDR earlier; we could not even have preliminary discussions with manufacturers until we were designated. But there was not the demand either. Given the short time frame until the full application of the MDR, and the lack of available guidance, common specifications, harmonized standards, as well as several unclear areas of legislation, and delays to Eudamed, there has not been a big appetite among manufacturers to rush for MDR compliance.
I am confident we will be able to complete conformity assessments for all manufacturers wanting to be compliant by May, especially given it is not a vast number. We anticipate the biggest demand to be for auditing of Class I reusable products, such as surgical scalpels.
There has been a lot of discussion in Brussels about whether these products will benefit from the four-year grace period. Our advice is that until a corrigendum is published to this effect, manufacturers are taking a risk if they delay with these products.
It will be interesting to see how industry responds. It is a difficult decision for manufacturers as they have finite resources, and if they believe the situation might change for Class I reusable instruments, they may feel compelled to divert resources to other key areas. But for those companies who are asking us to audit their products now, if they are compliant in time, we are sure we will get them through by May.
The majority of applications we have had over the last year or so have been for renewals under the existing directives. We have experienced something like three-times the amount of applications for renewals compared with what we would normally expect over this timeframe, as companies choose a more predictable route to market than the MDR given how piecemeal implementation activities have been so far.
Most are for certificates that manufacturers would have been renewed over the 2019-2021 three-year period, but where companies are looking to renew their certificates before the MDR date of application of 26 May 2020.
There have been some MDR applications, but most of the work that has come into us has been renewals under the existing directives, and we are running at around three-times the rate we would normally expect. We are great supporters of the MDR, but I can see why manufacturers are opting for a more predictable approach through the current medical device directives, given the fact that everybody is still learning.
Slack: Of course, there is demand for MDR assessments for products which must come into line with the MDR next year. We have had been reviewing some interesting Class I reusable products, for example, which need to be MDR-compliant by 26 May 2020. But beyond that, there has not been an overwhelming demand for MDR applications yet.
Some of that is related to the fact that resources are already tied up with regulatory people managing the renewal process. But much is linked to the fact that there is still a degree of uncertainty in some key areas of the MDR implementation, such as what is sufficient clinical evidence, and what is the definition of equivalence.
Slack: We have taken on a significant number of orphan manufacturers under the existing directives, but not the majority. Like everyone else in the medtech notified body sector, we have concerns about the overall residual capacity for our IVD clients because that regulation is following fast behind the MDR.
Despite it being over two years until the IVDR date of application, we are investing heavily in the IVD team. Indeed, our separate IVD investment plan has been approved by the BSI board.
Also, now we have UK notified body designation under the IVDR, we are accepting applications under the IVDR. We are expecting IVDR designation in the Netherlands in December.
Slack: I think resourcing is certainly tough right now, certainly for BSI. But I think it will get better in the next year-to-18 months, as we move beyond the date of full application of the MDR.
Much of the resourcing issue is down to training challenges. While the biggest growth in new recruits has come in the last four years, and particularly in the last two-to-three years, and while we have some 700 personnel now, it takes a long time to train people. This is despite taking technical and design and development engineers who have at least five years of technical experience and higher education; they still need training on the regulations; that tends to take 18-24 months. We have invested heavily in training and have taken the risk of increasing costs ahead of revenues because we needed more people.
May 2020 will see a stop to MDD renewals and a significant increase in requests under the MDR. We expect to be in good shape then.