At the end of November, from the stage of the Siot 2022 national congress, Fernanda Gellona, general director of Confindustria medical devices, raised the alarm regarding the new CE certifications of medical devices. The entry into force of the new European Regulation (2017/745), which subjects all medical devices to a CE marking with more stringent standards than the legislation currently in force, has in fact made it necessary to re-certify almost all products on the market according to the new rules.
The new and more stringent requests dictated by the Regulation have slowed down on the one hand the work of manufacturers in submitting the required documentation and on the other of the notified bodies responsible for issuing certification for marketing. The original deadline, May 2024, would have introduced a real risk for patients and professionals of not having usable products, not being able to access innovation or falling into the hands of suppliers selling non-compliant products, obtained through imports or secondary markets.
We discussed it together with Giulia Magri, Quality & regulatory manager of Confindustria medical devices (the interview was released before the approval by the European Commission of the extension to 31 December 2027 for products belonging to the highest risk classes and to 31 December 2028 for those at medium and low risk Editor’s note).
«The Regulation provides for transitional periods whose expiry will be in May 2024 (now extended Editor’s note). In this period, all recertifications of European products are therefore underway. The European Commission recently updated the data reporting the expiries of the devices that are subject to recertification from 2022 to 2024. We are talking about around 1,200 certificates that expired in 2022, 4,300 that will expire in 2023 and around 17,000 that expire in 2024. In reality these numbers they include many more products because one certificate can underlie several medical devices.
We are faced with a bottleneck due to the fact that there are many expiring certificates to be renewed and the capacity of the entire infrastructure is not such as to allow the recertification of these products in the required time. The industry was the first to become the spokesperson for this critical issue but now the whole of Europe and all the actors involved are fully aware of the problem, including the Notified Bodies, third-party bodies designated by the European Commission precisely to certify products according to the new Regulation. The problem is even more complex than that: in addition to the products that need to be recertified, the slowdown risks also affecting the innovative products that are on the way.”
Is the risk of shortage?
Yes, the risk is real. In fact, failing to recertify existing devices and allow innovative devices to enter the market will on the one hand lead to the absence of medical products at various levels in European healthcare systems, and on the other will prevent technological progress from improving European health. Innovation risks leaving Europe: the uncertainty of this historical period may, in fact, make other markets more attractive for the industry.
Why do we talk about a bottleneck?
A certainly major problem recognized by everyone, even by the Notified Bodies themselves, is their ability to cope with demand. Ability understood as capability, or as the availability of resources that can be dedicated to this certification activity. The Regulations, in fact, expand the regulatory requirements that the medical devices produced must meet and raise the bar of the already known requirements.
All this translates into longer certification times. Furthermore, in Europe, there are 36 Notified Bodies, a lower number than those present with the previous directives, which however find themselves having to re-issue approximately 24,000 certificates by 2024. Another problem that was highlighted by the European Commission itself in a survey carried out among the notified bodies is the state of preparation of the technical documentation that is submitted by the manufacturer. As I was saying, many requirements are new and are new for everyone, so we still need to clarify and certainly the status of the applications submitted may present gaps due to the ability or otherwise to interpret the requests of the Regulations.
In this context, small manufacturers have certainly struggled more, having fewer internal resources to rely on. We are talking about a large number of companies given that, as is known, the medical device sector is largely made up of medium-small companies or start-ups. Precisely for this reason the European coordination group was asked to make available specific guidelines and interpretative documents on which manufacturers can rely to produce their dossier.
What are the updates from Europe regarding the taking charge and search for solutions for this problem?
On 9 December, the meeting of the Employment, Social Policy, Health and Consumers Council (Epsco) was held, one of the items on the agenda in the Health section was information from the European Commission regarding the transition towards the Regulation 2017/745 relating to medical devices. Health Ministers have recognized the urgent challenges of implementing the Medical Devices Regulation and the impact on the availability of medical devices and the quality of medical care for European patients, supporting the need to make changes to the text of Regulation 745 to regarding the transitional provisions.
The next step involves the European Commission developing a proposal specifying how it intends to modify the Medical Devices Regulation and under what conditions. This proposal was made publicly available in early 2023 and contains a series of solutions for the modification of Article 120 of the MDR, including the extension of the transitional provisions of the MDR until 2027 for high-risk devices and to 2028 for those at medium and low risk and the removal of the so-called. sell-off period (art. 120(34) MDR and art. 110(4) IVDR), upon satisfaction of specific circumstances.
Interested proposals, which now must be discussed and approved by the European Parliament and the Council so that they are published in the Official Journal of the Union and, therefore, can become effective. The next few months will certainly be central to defining the future of the sector.
