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Berlin – The National Association of Statutory Health Insurance Funds currently sees no evidence of medical device supply issues. Hearing a call from the Union faction in the Federal Health Committee to reform the European Medical Device Regulation (MDR), the association rejected criticism from industry and politics.
Industry associations, politicians, but also doctors have continually warned in recent months that the implementation of the MDR is causing supply problems for medical devices. In addition to increasing costs and bureaucratic requirements for companies, capacity bottlenecks in so-called notified bodies – which are responsible for mandatory certification and recertification – lead to considerable difficulties.
“Given these general conditions, numerous companies have already decided not to supply products for recertification in Europe, but to immediately withdraw them from the market or, alternatively, to approve them only in the USA through a simpler procedure”, write the CDU and CSU in your application.
Industry associations estimate that at least ten percent of companies in Germany and Europe will disappear from the market, especially small and medium-sized economic players. The federal government should therefore work harder for fundamental changes to the MDR at European level.
In April, the European Parliament agreed to postpone the deadline for new certifications in order to avoid serious bottlenecks. Companies now have another four years to convert their products to MDR requirements.
“The changes made to the MDR were correct and important. However, the core problem remains and cannot be resolved by delaying deadlines,” explained Christina Ziegenberg, head of the Regulatory Affairs department at the Federal Medical Technology Association (BVMed), at yesterday’s hearing at the Federal Health Commission.
There is an urgent need for further development of the MDR in order to reduce its most important weaknesses – lack of efficiency in procedures, lack of harmonization and excessive bureaucracy. It is mainly small and medium-sized medical device manufacturers that would suffer from these regulations due to lack of capacity.
From the perspective of the National Association of Statutory Health Insurance Funds, such warnings are exaggerated. There are isolated reports of shortages of certain products, such as catheters in pediatric cardiology, explained Matthias Dettloff, from the medical department of the National Association of Statutory Health Insurance Funds.
However, such individual cases are “used controversially to make the MDR seem worse than it really is,” he said. “We currently have no indication that there are serious supply issues.” The biggest problem at the moment is that there is a delay in the certification of existing medical devices by notified bodies, which already arose during the COVID-19 pandemic.
It also played a role “that the affected companies delayed certifying their products under the new law for a long time and the necessary renaming of the responsible notified bodies made slow progress in the first years after the entry into force of the Medical Devices Ordinance ,” writes the National Association of Statutory Health Insurance Funds in its statement on the request.
The problem of bottlenecks in Notified Bodies is also not as dramatic as it is often described, explained Royth von Hahn, Head of Medical and Health Services at TÜV Süd. The number of notified bodies has already increased significantly, but their number is not that important.
What is more important are the internal capabilities that notified bodies make available for certain product classes. And here too there have been great improvements in the recent past. “We can process all requests – not immediately, but on time,” he assured.
Dettloff was also confident that the certification delay could be reduced due to the extended deadlines and that certifications could be completed more quickly in the future: “The specified deadlines appear to have currently stabilized at 13 to 18 months. But it is certainly conceivable that this will accelerate as the system learns.”
The comparison with the US, where many companies would relocate their product launches due to shorter certification deadlines, is also not accurate. The time specified there only begins when the application documents are fully submitted.
In Europe, however, there is a problem that companies often submit incomplete applications – also due to a lack of better knowledge of the requirements. “We are very confident that there is still potential for acceleration and that we will soon reach times that please everyone,” he emphasized.
However, it was at least partially open to suggestions from the industry: BVMed complains about the lack of centralization in the certification system. There are different responsibilities for products, certification procedures, notified bodies and creation of guidelines.
“The establishment of a central, responsible and accountable medical device management structure with system-wide decision-making capabilities, along with the consistent application of principles of good administrative practice, would have significant advantages over the current MDR system,” he stated the association in its statement.
He explained that he could certainly imagine such a process, at least for products such as so-called orphan devices, which are only produced in small quantities. This could be located at the European Medicines Agency (EMA) or a newly founded body. © lau/aerzteblatt.de