Interview with Armand Linge
«Mathys products – already compliant according to the EU’s novel Medical Device Regulation»
Since May 2021, the EU has required manufacturers to provide evidence of the clinical benefit of their medical devices, among other things. The obstacles are high. However, thanks to its philosophy Mathys does already fulfil the requirements. Armand Linge, head of Regulatory Affairs at Mathys, spoke about the consequences for users, patients and the entire industry.
has a bachelor’s degree in nuclear physics as well as an advanced degree in engineering with a multidisciplinary profile. He has been working at Mathys as Head of Regulatory Affairs for three years. Aged 54, he is very familiar with the legal requirements as well as with the regulatory tasks and obligations.
He joined the MedTech industry by chance after graduating. By now, the native Frenchman can already look back on 26 years of experience in orthopaedics. Armand Linge has been involved in regulatory tasks and obligations for ten years and speaks four languages fluently.
Mr Linge, the EU has recently started treating Switzerland like a third country with regard to the approval of medical devices. What has happened?
Until May 2021, in the European Union (EU) a directive for the approval of medical devices, the Medical Device Directive (MDD), was in force. However, due to various product deficiencies, it became apparent that its requirements were not sufficiently stringent. By way of example, the scandal with the French breast implants that had to be explanted from thousands of women due to their flaws attracted a lot of public attention. Until then, Switzerland used to have a bilateral agreement1 with the EU that facilitated the trading, import and export of medical devices – regardless of changes to the Directive in the EU.
The EU has now replaced the Directive with a much more comprehensive regulation, the Medical Device Regulation (MDR). Switzerland accordingly adapted its own Medical Device Ordinance so that now it is being kept, with daily updates, 1:1 equivalent with the new European Regulation. However, as the existing bilateral agreement does not cover the MDR, Switzerland has nevertheless been treated as a third country by the EU ever since. Substantially, however, there are no regulatory differences. Manufacturers who have EU approval can market their products in Switzerland with little effort. For Swiss companies, the exigencies of an EU authorisation are comparable to the Swiss requirements and specifications.
What is new about the MDR?
The old Directive focused on product safety. This means that medical devices had to meet a certain quality standard. However, no evidence of clinical benefit was required. This has now changed substantially: Before a medical device can be approved, the manufacturer is now compelled to demonstrate that the medical device offers a clinical benefit. In addition, the legislator mandates at least 2 years of clinical follow-up before approval. Thus, follow-up studies must be carried out in a manner similar to that for medicinal products.
Users must report any problems with a medical device immediately. This is likewise comparable to the legal requirements for medicinal products.
«Mathys is among the few medical device manufacturers with MDR approval»
What challenges does the MDR bring?
Obtaining approval has now become significantly more laborious and complex for manufacturers of medical devices. Thus, we have to carry out specific MDR activities in order to be able to prove that all medical devices by Mathys conform to the latest state of the art. All evidence is available in our technical documentation and constantly being updated. And this is how it should be, as safety and effectiveness are crucial for our users. In addition, there are special databases that need to be newly maintained. However, my guess is that not all companies currently in the market will be able to make this effort and will sooner or later bid the market farewell.
What is the situation at Mathys?
At Mathys, we are in a very good position. It has always been our philosophy to keep an eye on the quality of our products and control the medical devices over the course of several years in clinical trials. We already have up to ten years of clinical experience that we can present to the public authorities. Therefore, right now we have already received the medical device approvals according to MDR for more than 30 % of our portfolio. The remaining 70 % are currently still under review. To us, this is more of a formality, and we expect to get the approvals in any case. This makes us one of the 9 % of all medical device vendors who have received medical device approvals under the MDR so far.
What about the other 91 % of manufacturers?
According to a report of the European Commission from December 2022, 6 % of manufacturers have not received MDR medical device approval. The remaining 85 % are still under review. The EU has granted medical device manufacturers a transition period until May 2024. After that, things were supposed to get serious. But there appear to be efforts being made to extend this deadline once more, so that the manufacturers get a little more time to provide the necessary data.
«Mathys’s commitment to clinical benefit pays off»
What advantages and disadvantages do you see for your customers as a result of MDR?
Above all, the new regulation offers hospitals that use medical devices by Mathys the security of complete legal compliance. In addition, they may safely assume that medical devices by Mathys that are approved in accordance with the MDR have yielded solid clinical evidence and undergone complete testing. In addition, they have the benefit of knowing whom they can consider a reliable supplier. Our current medical device approvals are valid until October 2027 and in all likelihood even beyond. Unfortunately, this does not appear to apply to all vendors. For the hospitals, however, the new regulation also means that they will have to check for themselves whether the products used so far are approved or not. If a supplier needs to be replaced, this may affect the surgical technique. There will also be more information and documentation requirements. All the medical devices must be used in accordance with the indications – so there is also a little more effort to be made by the hospitals.
At Mathys, what is your opinion concerning the new regulation?
There is now a bit more effort for everyone involved. Regarding Mathys, however, I personally believe that the effort is worthwhile for users and patients alike. It enables us to create more confidence in all medical devices approved according to the MDR. I assume that in the EU and in Switzerland there will now be fewer revision surgeries overall. This is of great importance to all our users. We are glad that at Mathys we can offer reliability and have already fulfilled our legal obligations.
Mr Linge, thank you for this interview!
1 Mutual Recognition Agreement, MRA