Dark Clouds over Europe?
At this moment the Trilogues, the negotiations between the European Parliament, the European Council and the European Commission regarding the Medical Devices and In-Vitro Diagnostic Devices Regulations, are still going on. As indicated in my previous blog post, no outcomes have been made public except for some rumors. Basically we must presume that all proposals are still being negotiated. Until the publication of the final document there are no certainties about the exact requirements.
But even without those final documents published and with many details still missing, the general picture is quite clear: Conformity assessment procedures will be more complex, manufacturers will have to use more clinical data to demonstrate compliance, post-market surveillance activities will have to meet higher standards and data management will become more important.
For IVD manufacturers this means many of them will no longer be able to self-certify their devices. Notified Body intervention will be needed for a majority of IVDs, which implies that the quality of the technical documentation has to be robust enough for external review and the evidence for demonstrating performance will have to meet higher standards.
Manufacturers of medical devices will have to re-certify their current devices, even if they have been on the market for years without any serious problems. The current set of clinical data referencing “equivalent devices” may become useless, as the equivalence will be limited to quite identical devices. Apart from that, the performance of the device needs to be demonstrated with clinical data from the device itself. So many devices may have to be tested in clinical evaluations again.
Currently there are 61 notified bodies accredited. But at a recent RAPS-NL meeting, rumors were that the European Commission’s database for Notified Bodies NANDO has fallen behind with keeping up on current developments, and that in reality there are now only 41 Notified Bodies left. Right now it is not possible to get confirmation about which Notified Bodies are preparing for the new Regulations, and which will stop their activities for the medical device industry. That means that manufacturers may suddenly have to find new Notified Bodies.
But there is an even bigger problem developing. The European authorities are in the process of creating teams of auditors for accreditation of Notified Bodies for the new Regulations. It is estimated that once the Regulations are published, these teams will need six months to prepare for the accreditations. And then they can process about 17 Notified Bodies per year during the 2.5 remaining years of the transition period. Anybody can do the math: It will be a struggle for most Notified Bodies to be ready to certify manufacturers in time for the new Regulations come into power.
Does that mean manufacturers will have to face long waiting lists for certification of their devices? Maybe not… There is a possibility that these manufacturers will take so much longer to get to that stage that this anticipated peak in the workload will be spread out over a longer period, because the manufacturers are not able to collect their clinical data. As stated above, they will have to perform more clinical investigations with their devices to demonstrate safety and performance. It may be quite a problem to get a test with a proven device approved by an ethical committee, but the main challenge will probably be to find hospitals that still have any capacity for such tests. Manufacturers that try to get their devices on the Chinese or Indian market may be able to use their results with local patients for these clinical data. But that may not be a viable option for all devices.
Apart from that, the administrative backbone of all this should be the new Eudamed, the European Database for Medical Devices. Although I am optimistic about the readiness of Eudamed in a timely way, I am also aware that Eudamed has a poor track record so far. The step from 33 users (Member States, EEA and European Commission) to about 50,000 or more (Member States, economic operators, citizens…?) is huge, and the amount of data mutations per any given moment in time could go up by 50 to 100 times. That is a challenging step in data management.
This all leads to a very worrying picture: Notified Bodies will not be ready in time, manufacturers will not have sufficient clinical data and therefore standard therapies will suddenly no longer be available. And this may happen even if Eudamed is introduced without any major problem. All these problems will also lead to significant slowing down in the introduction of innovations on the European market. The European patients may be paying a high price for what was intended to be an improvement of the quality and safety of devices.
Temperature of soup
In The Netherlands there is a saying: “The soup is never eaten as hot as it is being served.” In other words, maybe we should not worry too much about the darkest of these scenarios. What if two years into the transition period, it will become clear that manufacturers will not be able to have their devices certified? I am sure politicians will step in with “smart” implementing acts that will suddenly smooth out most of these transition problems. We may see “grandfathering” criteria for clinical data concerning longstanding devices; certificates may suddenly be extended; the capacity of EU-auditor teams may increase and Eudamed suddenly appears to have received sufficient extra funding to get it working. Wherever there is a bottle neck, I am certain politicians will take care so that they will not have to explain to their voters that lifesaving treatment is suddenly no longer available only because of formalities.
The coming years this industry will face huge challenges. But we should not despair, because at the end of the day we all want the same: Patients getting the best treatment available. So whatever the problem you are facing, know that it is in nobody’s interest if a safe and effective device is kept off the European market. And of course I will keep an eye open for you to signal whenever pragmatism prevails.
Ronald Boumans is Senior Global Regulatory Consultant at Emergo's office in The Netherlands, and a former senior inspector at the Dutch Healthcare Inspectorate.