As medical device companies digest the European Commission’s newly released medical device regulatory recommendations, MassDevice.com caught up with Serge Bernasconi, CEO of Eucomed and the European Diagnostic Manufacturers Assn. (EDMA), to discuss how the creation of a central FDA-like body to oversee pre-market medtech review for the European Union might impact the broader device industry.
On Wednesday, medical device groups were quick to criticize aspects of the new regulatory guidelines, which still need to clear hurdles before final implementation, saying certain updates stall innovation rather than bolster safety.
European authorities have been assessing medtech review standards, which haven’t changed much in 2 decades, since the European Commission in 2008 identified several vulnerabilities. Regulators came under intense pressure to revise security standards for medical devices after a wide-scale breast implant recall dramatically exposed weaknesses in the system.
MassDevice: The medical device community has long compared the U.S. regulatory system unfavorably to the EU, both in terms of time to market and predictability. Will these new recommendations from the European Commission change that?
Serge Bernasconi: No, I don’t think it will change the dynamic. Even with what is proposed in the recommendation of the commission, I’m not sure that brings the EU system closer to the U.S. system. [The recommendations] are really just clarifications of the overall system, which has been in place for many years, and most of the changes are basically needed. We support those ways to improve the system but if I look at it vis-à-vis the U.S. system, I’m not sure these recommendations would bring it close to the U.S. system.
The [medical device] industry in Europe to a large extent supports the recommendations made by the commission and really the only domain in which we have real concern and hopefully have changed is the issue of the creation of scrutiny panels.
The issue we have is that these [scrutiny panels] are something that comes on top of a system, which at the end of the day, has worked well, has provided safe products to patients.
We don’t see this proposed extra layer as bringing anything significant to the game. In particular, when it relates to patient safety, fast access to technology for patients and further development of innovation in Europe, which has been fertile ground for developing innovations.
What we see is that already, through these recommendations alone, if implemented correctly, would significantly raise the standards of notified bodies. We support the fact that notified bodies need to be better controlled and that we need to make sure we have quality work that comes out of notified bodies.
This is absolutely critical for being respected and trusted by patients. That’s why we support what the commission wants to do. We support the fact that member states, which have responsibility over the notified bodies implement strongly the capacity to control. We support the fact that there be unannounced audits and we believe if we start to do this, frankly we don’t see the need for the scrutiny process. It will make things significantly more complex and it will significantly extend time to access for devices.
Larger corporations will most definitely be able to handle this change. However, this would be a significant challenge and potentially push away small and mid-size enterprises from the European market, which is a pity because today this is the largest segment of companies that we have in Europe. Those companies may not be able to support the changes.
MassDevice: Can you walk me through how the proposed scrutiny panels extend the run ramp for these companies? Do these scrutiny panels look at the notified bodies in general or is do they look at devices on a case-by-case basis?
SB: The system that they are proposing to put in place says that they would like to provide the committee the ability to call upon certain files under 4 conditions:
The 1st condition is that this scrutiny mechanism should only be related to Class III devices.
The 2nd condition is when there is evidence of public health concern within that therapy. For example the breast implant industry.
The 3rd condition is when you have an extremely novel technology, where there is limited experience in human research technology.
Finally, the condition that they could call on any files of notified bodies that have a history of significant discrepancies so they could look into it and say ‘We’re not sure about this notified body, do they really have the competence to do this or not?’
And, the commission is looking into legislation to expand the scope of scrutiny to other device categories, which we’re concerned about.
MassDevice: In essence, it’s the ability to pull any file that fits into those criteria?
SB: They can call on any file based on these factors and that’s the issue we have for SMEs; you don’t know ahead of time if you’re going to be called in or not, which as designed could significantly extend the time it takes to get to market. These are products with a relatively short lifetime, 18 to 24 months, before there’s new technology coming through. Within that time you could also have another competitive technology coming through and they could end up ahead of you.
MassDevice: So, it’s similar to the issue in the U.S. with the FDA’s premarket approval process where companies have a difficult time predicting time lines?
SB: Yes, exactly. At the end of the day we don’t want people to feel that as an industry we take a position against scrutiny. What we would like to see is that anything we put in place responds to 3 key questions. The 1st question being ‘does what we put in place improve patient safety?’ The 2nd question is ‘does it maintain or extend access to patient technology?’ The 3rd question is ‘does it encourage innovation and investment?’ What we see is when you ask this question and look at what’s proposed with the scrutiny process, we are answering "no" to all 3 of these questions. And, there is a system in place that is already working.
MassDevice: This industry is multi-national. Will it just look towards other markets and away from Europe as a result of uncertain regulatory environments?
SB: Well, that’s something that could happen and we would not want to see it happening. Right now, we like the idea that Europe is the 1st stop for new technology and we would hate to see this moved to another region of the world. At the end of the day it’s not only for the sake of corporations, it’s for the sake of patients and the healthcare system in Europe. These innovations are significant contributors.