21.03.2024
Interview Armand Linge
«Complex EU legislation for medical devices: all of Mathys products comply with the law»
Medical devices were subject to the Medical Device Directive (MDD) up until 25 May 2021. However, since 26 May 2021, the EU Medical Device Regulation (MDR) has placed much stricter requirements on medical devices. Only a few manufacturers will be able to meet these requirements by 26 May 2024 when the transition period comes to an end. However, according to another new law, expired MDD certificates can now be extended with a ‘Confirmation Letter’ issued by the regulatory authorities. Armand Linge, Head of Regulatory Affairs at Mathys, knows what clinics need to look out for.
Armand Linge
Armand Linge has a multidisciplinary profile with a bachelor’s degree in nuclear physics and an engineering diploma. He has been Head of Regulatory Affairs at Mathys for four years. The 54-year-old is very familiar with the legal requirements and regulatory tasks. He entered the medtech industry by chance after finishing his studies. The native Frenchman can now look back on 26 years of experience in orthopaedics. Armand Linge has been working in regulatory affairs for more than 25 years and speaks four languages fluently.
Interview
Mr Linge, a year ago around 30% of Mathys products were already compliant with the new Medical Device Regulation (MDR). Where are we now and what happens to products that haven’t yet achieved MDR conformity by 26 May 2024?
At the moment, more than 70% of our products already comply with the MDR. So we took a major leap forward last year and are very pleased with this result. Originally, the European Commission planned that all products that have not received a valid MDR certificate by 26 May 2024 will no longer be marketable, at least temporarily. In reality, this would mean that a large proportion of medical devices would have disappeared from the market. The European Commission recognised this problem in good time and published a very complex law in March 2023 that extended the transition period for MDD products.
So all medical devices can continue to be used even after the deadline?
No, not quite. This is not such an easy question to answer. In strictly legal terms, the MDD certificates for products that are not MDR-compliant by this date have expired. It’s a bit like a passport: It has a registered validity but becomes invalid. This means that in legal terms there are currently only two states: ‘valid’ and ‘invalid’. However, the European Commission has now created a third path with the law passed in March 2023: medical devices with an expired MDD certificate, which therefore have the status ‘invalid’, can still be placed on the market under certain circumstances. They fall into this category if they have received a Confirmation Letter from the notified bodies. These medical devices are then subject to different extension periods for their use. We already have a Confirmation Letter for all our products.
«Previously, products could only be “valid” or “invalid” under the law. But now we’ve got something in between.»
How much of a grace period is granted to medical devices that are not yet MDR-certified?
That depends on the risk class of the medical device. Class III and Class IIb implants may be used until 31 December 2027 if they have a Confirmation Letter. Class IIa medical devices and those in Class I have a deadline extension until 31 December 2028 with a Confirmation Letter. The difficulty is that users in clinics and surgeries often still have products that comply with the MDD in stock. There’s no way of knowing which medical device now has a Confirmation Letter or is already MDR-compliant.
How should this be communicated?
Manufacturers are obliged to submit the Confirmation Letter to customers, distributors and authorities, especially customs authorities. The letter has been formally issued by the European Commission and looks very complex. Unfortunately, we cannot influence this but we adhere to these guidelines. One thing is certain: all of Mathys implants and instruments are either MDR-compliant or have a Confirmation Letter in place for after 26 May 2024. This means that Mathys products are all legally compliant and can continue to be used.
«Mathys is in a very good position compared to other medical device manufacturers.»
How are non-European markets dealing with this new situation?
The deadline extension is also causing confusion in non-European markets, as the status of a valid ‘invalid’ medical device has not yet been legally recognised anywhere. This applies to the markets in Japan, Brazil and Australia, for example. A regulation must be developed for medical devices with this kind of extended authorisation. This is a challenge that we will have to overcome in the future.
What do you hear from other medical device manufacturers?
All different things. At the moment, around 8% of medical devices are MDR-compliant. For some products it’s very difficult to provide evidence of the necessary studies, as has already been reported in the press. This applies to medical devices for paediatric operations, for example. The European Commission is well aware of this problem.
«Mathys is happy to help clinics and users if they have any questions.»
What do you think about the new MDR update?
Generally speaking, Mathys is very open to the MDR and further updates. The fact that all medical devices have to prove their safety and efficiency makes a lot of sense. We have already handled this in the past out of our own interest and the quality of our products has been monitored closely. This is the reason why we can also provide reliable data for all our products and so have no issues with MDR compliance. However, it should be said that exceptions must be made for applications that cannot be represented in studies. I would like to emphasise once again that Mathys is always available to answer any questions customers may have about our products.
Mr Linge, thank you for this interesting interview!
