The countdown to May 26, 2020, is on. That's when device makers have to comply with the European Medical Device Regulation, designed to ramp up stringency and breadth of pre- and postmarket review infrastructure after regulators cited problems with "diverging interpretation" of existing medical device policy and decreased consumer confidence following the PIP silicone breast implant scandal.
But the designation of EU notified bodies — which are responsible for certifying medical products under the new regulation — is lagging, stoking fears there won't be adequate capacity to deal with the new regulation.
And the industry has done little to quell those concerns. This spring, U.K. notified bodies Lloyd's Register Quality Assurance and UL International, and Swiss notified body QS Zürich all announced plans to pull back from the medtech sector. Their reasoning ranged from the high level of financial investment needed to meet the new standards to concerns over losing designation in the event of a no-deal Brexit.
But notified body BSI Group has followed a different path. BSI was the first to be designated under the new MDR regulation in January 2019, and it expects to be designated in September in the Netherlands.
Gary Slack is BSI Group's senior vice president of medical devices. Slack, who's been with BSI since 2008, has worked in the industry since 1994. Prior experience includes stints at Cardinal Health, Boston Scientific and Medtronic. He's been intimately involved with all of BSI's EU Notified Body activities, including manufacturer site audits and assessments, and product certifications.
MedTech Dive asked Slack about how BSI is preparing for the incoming EU medical device regulations, the impact of Brexit and whether the European Union will have the notified body capacity needed to support the incoming Medical Device Regulation.
This interview has been edited for clarity and brevity.
MEDTECH DIVE: How is the issue of constrained capacity playing out in the EU?
SLACK: It's quite difficult to find a notified body at the moment because everyone's kind of overwhelmed. The dropout of a significant number of notified bodies could potentially affect patients directly. Notified bodies dropping out is not a good thing for patients in the long term. We don't see it as a positive.
MEDTECH DIVE: What are the effects of this lack of notified bodies for industry?
SLACK: What we're already seeing, particularly for smaller manufacturers, is they are struggling to find a notified body to take them on. Many are just struggling to get their existing certificates renewed before the new regulations come into play in May 2020. The lack of capacity could make it tougher for manufacturers to get existing product to market and may even slow down the introduction of products to market. We have some empathy about why the industry is concerned about the rate of designation.
MEDTECH DIVE: Lloyd's Register Quality Assurance cited concerns about the market as a reason for exiting the notified body arena and the Swiss notified body said it left because it didn't have capacity; do you share those concerns?
SLACK: We have a different view from them. We're by far the largest of the notified bodies in terms of manufacturers and certificates. We're a full-scope notified body. We have 700 plus people. We're investing heavily and we see it [the market] as a positive.
MEDTECH DIVE: How is the capacity situation affecting BSI?
SLACK: We're focused on making sure our existing manufacturers are being looked after. We're not taking on new clients in certain sectors. We're overwhelmed with work in certain sectors like orthopaedics. We're sort of seeing an atypical volume and, on top of that, we're getting applications under the new regulation. This year, we have probably two to three times as many renewals as we would see in a normal year. Because of the atypical demand driven by next May's deadline, manufacturers have been trying to renew all of those now, simply because the amount of work to put together applications under the new regulation is vast.
MEDTECH DIVE: What are some of the positives you see coming from the new regulation?
SLACK: One of the nice things about the new EU MDR regulation is it gives us a chance to update on those areas [where there have been] significant, dynamic changes in technology over the last three or four years. And the joint audit program is another mechanism to ensure oversight of each competent authority isn't different. It'll provide for a more consistent application of regulations across Europe than we've had in the past and it maybe has the potential to raise the bar. That might be some of the reason behind some of the drop-offs [in notified bodies] you're seeing.
MEDTECH DIVE: Was the certification process cumbersome?
It's a complex and long-winded process. It took us 26 months to get the MDR designation, but we expected that. It's a very rigorous process. It's complex and in-depth but, at the end of the day, it's designed so you have a really competent notified body. It's trying to deliver much more consistency across EU notified bodies.
MEDTECH DIVE: How is the prospect of Brexit affecting your business?
SLACK: The reason we're in two countries is we have the wonderful specter of Brexit in the background. This way, we make manufacturers more secure if Brexit happens. We physically migrated 95% of our clients and certificates to the Netherlands before March 29 of this year to reduce the risk of Brexit. Pretty much everyone we were working with moved with us to the Netherlands; other U.K. notified bodies were slow to do that. A very small proportion of our clients elected not to do so, mainly small companies or those who did the bulk of their business in the U.K.
MEDTECH DIVE: What is the worst case Brexit scenario?
SLACK: The worst case is on the 31st of October of this year, there would be immediate withdrawal, the U.K. NB could no longer provide EU services but would remain a certified body under the new U.K. regulation.
MEDTECH DIVE: Why did BSI choose the Netherlands for its second location?
SLACK: It's a relatively straightforward country to deal with. Specifically, we saw the competent authority in the Netherlands as being of a similar outlook to the MHRA [The Medicines and Healthcare products Regulatory Agency ] in the U.K. where the approach and general philosophy of oversight was relatively similar to the U.K. The EMA [European Medicines Agency] also moved to Amsterdam.
MEDTECH DIVE: The European Commission reportedly has estimated it expects a total of 20 notified bodies to be designated by the end of the year. What is your view on whether that's likely to happen?
SLACK: I personally think it's a little optimistic. Currently, we only have two. [TÜV SÜD was designated in May].
MEDTECH DIVE: Currently, no notified bodies have yet been certified under the In Vitro Diagnostic Regulation, which will come into effect in May 2022. Does BSI have plans to become certified for IVDR?
SLACK: We expect to be designated in IVDR in September or October of this year. We should be one of the first ones designated.
Maria Rachal contributed to this piece.