Facing the MDR: Kiwa races to help customers transition
Huge numbers of medical devices manufacturers will have to transition from the European Medical Devices Directive (MDD) to the far more stringent Medical Devices Regulation (MDR) to be able to market their products. They all will have to comply with the MDR by May 2024, so time is very short. Kiwa Cermet in Italy and Kiwa DARE!! in the Netherlands are Notified Bodies designated for MDR. Together with our branch office at Kiwa Tükiye, they help clients throughout Europe, and beyond, with this challenge.
What this is about
Healthcare professionals use all kinds of medical devices to improve and save patients’ lives. These devices are designed and manufactured to diagnose, treat, monitor and help people, but can be downright dangerous when faulty or low quality. The European Medical Devices Regulation (MDR) sets out stringent requirements for such devices, thus helping to improve their quality, safety and the transparency of the market. At the same time, ensuring compliance poses a challenge for all economic operators involved.
Why the MDR came about
The MDR replaces the European Medical Devices Directive (MDD), which had been in effect since 1993. A lot changed in the subsequent 20 years in terms of innovation and technology, and there also were some high-profile scandals that caused widespread attention to medical device legislation. In 2012, the European Commission (EC) therefore decided to update the laws to maintain a high level of safety while supporting innovation. Devices for aesthetic purposes were included as well (the MDD did not cover those). The resulting MDR was finally published in May 2017 and became applicable on 26 May 2021.
What Kiwa has to do with this
Kiwa services a wide range of customers in the Medical Devices sector. Kiwa Cermet in Italy, Kiwa Türkiye and Kiwa DARE!! in the Netherlands all were authorized to certify manufacturers against the MDD. Both Kiwa Italy and Kiwa DARE!! have been designated Notified Bodies (NoBo) for the MDR. As such, they belong to a relatively small number of NoBos in Europe. At Kiwa Türkiye, a Kiwa Cermet authorized branch has been established as an ‘international’ NoBo to assist customers there.
Status: hundreds of clients to go
In January 2022, Kiwa Cermet Italy issued the first two certificates according to the MDR to a company called ASCOM, for a quality management system and technical documentation for a stand-alone software device for clinical patient management. More certificates for other companies followed.
Still, there is a long way to go, says Mehmet Fevzi Gülünay, Deputy General Manager at Kiwa Türkiye. “From Türkiye, we service over 400 clients in the Medical Devices sector. Many of them still operate under the MDD, but they will have to comply to the MDR by May 2024, when it will become mandatory. Currently, just a handful of them are ready to be assessed.”
As the MDR is far more stringent than its predecessor, preparation time and effort for manufacturers and other players is much greater. For NoBos like Kiwa, the workload is bigger as well. “Processing a customer’s application for the MDR alone takes two to three days to complete”, Mehmet illustrates. “The certification process itself digs far deeper and is more comprehensive, thus more time-consuming and costly – which poses a challenge for all involved.”
He sees a possible side effect that might alleviate things a bit. “We’ll continue to do what we can, we’ll continue looking for the right new colleagues, and we’ll continue urging our customers to take action. Still, my estimation is that only about half of the medical devices will be MDR compliant by May 2024. On the one hand, that might be worrying. On the other hand, I think each EU country will generate its own temporary solution for that, and will go on from there. We simply can’t do without safe medical devices. And we at Kiwa will do anything to contribute.”