Until recently, regulations concerning medical devices and IVDs consisted of European directives. The member states had to transpose the directives into their own national legislation, which had the disadvantage of creating divergences ... Moreover, these guidelines were issued in the late 1990s. In nearly three decades, the world of medical devices and IVDs has changed enormously. A serious update of the legislation was therefore necessary.
In 2017, the European Union (EU) published regulations on the subject. These texts leave only a small margin for the member states to impose national provisions. Indeed, most articles are not subject to interpretation: the rules must be implemented in their entirety throughout the EU. These new legislations, which came into force in May 2021 for medical devices and in May 2022 for IVDs, have a huge impact on the functioning of manufacturers but also on importers, distributors, healthcare professionals, hospitals and on the experts of our agency.
IVD stands for in vitro diagnostics. This acronym refers to tests used on human samples to provide medical information for, for example, making diagnoses on patients, checking the compatibility between donor/recipient, defining a treatment. IVDs include COVID tests, HIV tests, pregnancy tests, blood grouping tests, etc. Approximately 80 % of patients’ treatments start after using an IVD. It is therefore a very important group among medical devices.
One of the most significant changes in the new IVD regulation is the marketing conditions. In order to place an IVD on the market, manufacturers must issue a Declaration of Conformity for their IVDs that certifies that they comply with applicable legislation. Under the previous legislation, for the majority of IVDs, manufacturers remained the sole actors in the conformity assessment of their IVDs. And in only a minority of cases, the manufacturer had to use a notified body (an external company appointed by the member state authorities) to certify their device before issuing their declaration of conformity. With the new legislation, the opposite is the case. In most cases, manufacturers must go through a notified body.
Another important change is the creation of reference laboratories for IVD at the European level. These laboratories, which are expected to be operational by the end of 2023, will be tasked with monitoring the performance of the highest-risk IVDs.
Our experts in the field of IVDs
The almost systematic use of notified bodies changes many things: previously, only 20 % of IVDs had to pass this type of check. Today, we are talking about more than 80 % … This new operation has many advantages, including the essential one of ensuring a better quality in terms of safety and performance of the IVDs present on the European market. Unfortunately, this approach also has its drawbacks: certification takes time (especially since, for the moment, there are still too few designated notified bodies), involves numerous administrative requirements and has a significant cost. Therefore, some manufacturers may prefer to remove (part of) their IVD from the market rather than go through the entire certification process.
This new legislation has many benefits for EU consumers but adds a significant amount of work for manufacturers. And not only that. The FAMHP teams have also had to adapt. It is necessary to guide all actors towards all the changes (including the rather important one of major modifications in the IVD classes), to guide them in the new procedures and ways of functioning and to answer the numerous questions. This work will certainly continue in the years to come.
In addition, because the certification process under the regulation is still in its early stages, some manufacturers find themselves without a certificate for their IVDs. For this reason, the European Commission has put in place transitional periods to limit shortages in the market. Most IVDs that complied with the previous legislation can under certain conditions continue to be marketed until 2025-2027 depending on the classification of the IVD. In exceptional cases, it is also still possible for the FAMHP to grant derogations to market an IVD whose manufacturer has not completed its conformity assessment, at the request of the manufacturer. This process is even more important for critically important IVDs that could no longer be marketed due to this change in legislation.
Consumers can rest assured that there is no shortage of IVDs on the European market (yet). The EU countries are currently in a transition period. As the years go by, more and more IVDs will comply with the regulation. In addition, in 2024, Eudamed, a common database that was supposed to be finalised in 2020 but whose development has been delayed due to the health crisis, should be available in its entirety. As of the official publication of Eudamed, the obligations related to this database will start to enter into force. Actors related to medical devices and IVDs will be obliged to enter different information such as contact details of actors, information related to medical devices and IVDs, certificates, traceability data, incidents … In principle all data will have to be registered by 2026. The FAMHP and the other competent authorities of the member states will thus be able to access a lot of information to facilitate market surveillance. This will require a change in the internal processes of our agency.
The new IVD legislation comes with its own set of challenges, particularly for manufacturers but also for the FAMHP. However, in the coming years and with the completion of some major projects (designation of Notified Bodies and EU Reference Laboratories and Eudamed), European patients will be able to benefit from safer and more easily traceable IVDs. The FAMHP will participate with professionalism and expertise in all future changes.
If an IVD, either a previously compliant IVD or a new IVD, has not been able to obtain its CE certificate under the regulation in time (an obligation that is still difficult to meet due to the small number of designated notified bodies), it is therefore possible for the FAMHP to grant a temporary derogation to the manufacturer at his request to place or continue to place his IVD on the market. These derogations are obviously not granted lightly: they are only justified if they are necessary for public health or patient health or safety. This is the case when a product is essential for patients and there is no alternative on the Belgian market. These derogations may apply to medical devices or to IVDs. During the coronavirus crisis, this was for example the case for surgical masks (medical devices) that complied with European standards but did not have the CE mark or for antigenic self-tests for COVID-19 (IVD) that were in the process of being certified. More recently, an essential product for organ transplantation could have disappeared from the market for administrative reasons. A derogation was granted for the product. In 2022, such temporary derogations were granted for about 60 cases.
The members of the Advisory Board
The decision to grant a derogation, even a temporary one, is obviously not made lightly. These files are discussed at the Advisory Board, an internal body composed of all the teams that manage medical devices and IVDs within the FAMHP. The Advisory Board meets every two weeks or at any time in case of emergency. It provides advice on problematic dossiers such as requests for derogations, but also incidents that justify product recalls or not, stops of clinical investigations … The advice is provided to the CEO of the FAMHP or his delegate who makes the final decision. The objective is to have the input of each party (clinical study, possible incident …) before providing an opinion as fast (the issue is often resolved in a few days) as informed on the decision making. As in all other aspects of their work, the FAMHP experts have as their priority the health of Belgians and the continuity of their care without negotiating on the quality, efficacy and safety of the products on the market.