Since 26 May 2021, a new European regulation for medical devices has been in force, and new rules for in vitro diagnostics will also come into effect in 2022. The new legislation entails various changes, for example, products can now fall into a different risk class and must meet stricter safety and quality requirements. The new European legislation therefore has a major impact on manufacturers, importers, distributors and all other actors in the industry. At the FAMHP, various procedures have also been updated, and new tasks have been taken on. Colleagues Alexandre Jauniaux, Christophe Driesmans, Katrien Martens, Steve Eglem and Valerie Nys talk about the preparation and state of affairs of the new legislation.
How did the legislation for medical devices and in vitro diagnostics work previously?
AJ (head of the Health Products Division): First of all, it is important to know that the field of medical devices is very broad: there are more than two million medical devices on the market. Before the new regulations, Regulation (EU) 2017/745 and Regulation (EU) 2017/746, came into force, we needed to comply with three European directives.
The first was Directive 93/42/EEC, which applied to all medical devices. This covered almost anything with a diagnostic or therapeutic purpose: from software to medical devices for diagnosis or medical devices for contraception.
The second was Directive 90/385/EEC, which applied to active implantable medical devices. These are devices that rely on an energy source other than people or gravity: as such, they are primarily battery-powered devices, such as pacemakers.
Finally, there was Directive 98/79/EEC on in vitro diagnostic medical devices. These are devices used to determine physiological parameters, such as PCR, antigenic or serological tests to detect COVID-19.
These three directives applied to everything relating to medical devices, from manufacturing to their use and marketing.
Why was there a need for this new legislation? What exactly was the aim?
AJ: The two regulations published since 2017, Regulation (EU) 2017/745 and Regulation (EU) 2017/746, are intended to provide greater transparency of data on medical devices, and they are also intended to improve the traceability and safety of medical devices. In the context of the two regulations, the Eudamed database was set up, to allow the various authorities competent for medical devices, actors and the public to access common and shared specific data on medical devices. This will ultimately lead to better quality and safety of devices.
VN: The emergence of the new legislation prompted a minor revolution within all FAMHP services that were involved with medical devices. The Executive Council therefore decided to appoint a project manager to oversee the changes at a transversal level. All necessary updates to processes, legislation, ICT and communication were followed up transversally to ensure a common and coordinated approach within the different services involved. We started this project in 2017, even before the regulations were enacted, to be ready in time. The biggest challenge was undoubtedly connecting our applications to the European database Eudamed.
What has improved for your field as a result of this new legislation?
KM (head of the Medical Devices Division): What we are very happy with in the new legislation is that the obligations of the different actors are more clearly defined. There are now specific articles with the obligations for the manufacturer, the representative, the distributor and the importer. In Belgium, we had national legislation for distributors, but there was nothing at the European level.
Now, for example, the regulations specifically stipulate what elements a quality system must contain and what must be in the technical file. For our inspection services, of course, this makes the job a lot easier. If everything is clearly defined, it is much easier to get everyone on the same page. As a result, there is also less room for individual interpretation and therefore less room for disagreement. Although, unfortunately, the new texts still contain various elements that are open to discussion and interpretation.
SE (head of the Clinical Trials with Medical Devices Entity of the Research and Development Division (human use): As regards clinical trials, also known as clinical research and performance research, a lot has changed. The major difference is that the emphasis of the directives was mostly on the phases after the medical device had been placed on the market. This was primarily because the manufacturer could only rely on clinical data published in literature to place a similar device on the market.
With the two new regulations, this becomes more difficult, as the manufacturer will have to prove that they had effective access to the technical documentation of the competitor’s device to which it is referring before this clinical data can be used. In practice, this will increase the safety of medical devices, which is obviously very positive. For in vitro diagnostics (IVDs), the directive contained little information regarding clinical trials, besides from notifications. With the new regulations, a permit application is now required, and that brings with it a set of new requirements.
It is therefore quite an adaptation, both for us and for the manufacturers and sponsors. We have seen another important change in the certification of in vitro diagnostics. Self-certification used to be possible, but now an assessment by a third party, a notified body, is required. This body will verify the technical documentation of the medical device in question before it is placed on the market. Robust and reliable clinical data will therefore need to be provided. This will likely mean that many more studies will have to be edited in the future. But of course, these measures are all in the interest of patient safety.
CD (head of the Materiovigilance Unit of the Vigilance Division): The new legislation is a major step forward in various areas, but the greatest progress is yet to come. In 2023, the European database Eudamed will definitively enter into force. Manufacturers will need to register themselves and their devices in this database, thereby providing a clearer picture of all manufacturers of medical devices. Among other things, all serious incidents involving medical devices will also have to be entered into a European database. Putting all the data together within Europe, of course, gives the possibility of investigating incidents much more effectively. Manufacturers will also have to provide an overview every year on all the activities they carry out after their products are placed on the market. That is undeniably a major step forward.
The new regulations are clearly a step forward, but what impact does that have in practice on your daily tasks?
AJ: Within my division, we have had to update all processes. All notifications now go through the Eudamed database, meaning that the administrative burden is shifted to the actors. On our side, we will be more involved in market surveillance, monitoring registered devices in Eudamed: thematic actions, coordination with the Directorate General Inspection, etc. We will therefore have to completely change the way we work.
KM: We will indeed have to adapt our procedures, but the inspection has not completely changed. As our colleague Christophe said, the big change will come when the Eudamed database comes into effect. Then ultimately we will know all our actors, because currently not every importer, agent or manufacturer has to register. If we have accurate data, it will be much easier to organise inspections. This will be a great improvement for us to have a better understanding of our market.
How has the new legislation affected the workload?
CD: It has increased significantly. The new legislation has shifted new tasks to us. There are also more elements that we need to monitor. Collaboration is also much more important. The new regulations stipulate much more clearly how we need to collaborate, how we need to plan, how we need to work with other member states. 33 guides were published last year for the new legislation. We worked with the other member states to draft and verify these texts.
SE: The workload has clearly increased for everyone. Especially given that we have now moved from European directives framed in national legislation to stricter European legislation. This also requires more unity at the European level: guidelines, a common interpretation, closer cooperation, coordination of given assessments, etc.
CD: The new regulations pertain to various actors, but primarily manufacturers. The fact that we are responsible for everyone is often overlooked. For distributors, manufacturers, some hospitals, doctors too. We need to try to get these parties involved in the bigger picture. We need to draft additional legislation, but also explain how this legislation works, what has changed. This therefore involves a lot of tasks, so that the stakeholders know the legislation and follow it properly.
AJ: There is a heavy workload for all actors in the field, but also for competent authorities, notified bodies and even the European Commission. The workload has really increased for everyone: there has been a fivefold increase in the workload for staff. But this is the case for everyone and will require reorganisation and a lot of time.
Do you see any difficulties that the sector still has to overcome?
AJ: The actors are not so happy. More safety means more control by notified bodies. This means longer procedures, and the workload of the notified bodies has therefore increased as a result. Everything has been turned a little upside down.
SE: All of these changes also impose significant costs on the sector. And that may have consequences for the market in the long run …
KM: We then run the risk that companies will have to make economic trade-offs and a lot of products will fall by the wayside. We already often hear these signals. Products that are already on the market will also have to be updated by the new legislation or they will have to be recertified. If that doesn’t stack up economically, manufacturers will have to make a tough choice.
So … more work for everyone, but more transparency and guarantees for health. To conclude, let’s look ahead to the future. What still needs to be done now that the new legislation has entered into force?
CD: At the moment, we are mainly looking forward to the full entry into force of the Eudamed database in 2023. To this end, we have reworked our entire ICT system for programs and databases. The database is already partially active, but using it is voluntary and not mandatory. From next year, all actors will register themselves and their resources in the database. Then we will really have a good overview of the European market. That will really be a new start.