(04/2021) The MDR traffic light is yellow. But are all those involved in the market really waiting until they can finally get started with the European Medical Device Regulation at the end of May? Before that, there is one hurdle to overcome: the so-called audits. How manufacturers can successfully pass these tests by the Notified Bodies was the focus of a symposium organized by the MedicalMountains branch network from the Tuttlingen area. More than 100 participants from Germany joined the online forum in February.
By postponing the implementation deadline by one year to May 26, 2021, a lot of relief was initially noticeable in the industry. But the problems were only postponed and in some cases the market is still where it was in 2017 when the MDR came into force. Dr. Bassil Akra has known MDR and the market for years, including from his work at TÜV Süd. He moved from the Notified Body as managing director to the consulting company Qunique GmbH with locations in Switzerland and Germany.
The named bottleneck
And the Notified Bodies factor will become a bottleneck when it comes to implementing the MDR. While more than 50 positions were named for the previous MDD regulations, 19 had just been accredited for the MDR by mid-February. Special areas such as B. implants, only cover individuals. As a result of the pandemic, not only the MDR deadline was postponed by one year, but also the due audits at the manufacturers. Due to contact and travel restrictions, many notified bodies were unable to perform their tasks. And in some cases this is still the case today, because although the employees from domestic offices can travel to the manufacturers, those from abroad cannot.
Enable remote audits
And remote audits made possible by the EU are not allowed in all countries. So the German government should pave the way for this. Notified bodies are ready to use this procedure if it is feasible and practicable. It could definitely make their job easier. Manufacturers should also clarify details with their supervisory authorities and notified bodies.
MDD and MDR in parallel
In addition, the Notified Bodies are currently certifying MDD and MDR at the same time, which further limits capacities, says Dr. Akra. Because many bodies have not yet submitted an application for accreditation according to the MDR, manufacturers should ask their notified bodies whether they will also work for the MDR. Manufacturers can also have valid MDD and MDR certificates until May 2024. But even if a company still has a valid MDD certificate, it must follow the MDR requirements for market surveillance.
Bottleneck in the EU
The speaker also identified another bottleneck at the EU Commission. The EU is also looking for specialists for an expert group responsible for the MDR who could start work in April / May. There is also a lot of work to be done on the part of the EU over the next three years. There are now many so-called guidance papers, but these still leave a lot of room for interpretation, according to Dr. Akra. In addition, a lot of information was still missing from the EU for market participants and notified bodies. Dates for the respective publications would be shifted regularly, e.g. B. on the harmonized standards.
Hurry
“Please wait” aptly describes the situation. However, manufacturers shouldn't wait any longer and put their hands on their laps until all of the papers are in place. Accordingly, after consultation with the Notified Bodies, the internal processes and documentation should be prepared according to the current state of knowledge
