Has the EU Medical Device Regulation overshot the mark?

The EU Medical Device Regulation (MDR) has applied since 26 May 2021, significantly extending the legal specifications for the medical technology sector. This EU Regulation comprises 123 articles and 17 attachments amounting to a total of 175 pages. The German amendment act comprises 99 paragraphs, whereas the previous German Medical Products Law (MPG) contained 44 paragraphs. 

The MDR represents a huge extra effort for medical product companies, for example, on account of the requisite personnel increases and greater bureaucracy involved. Around half of the companies participating in a survey by the Federal Association of Medical Technology (BVMed) incurred extra financial costs of more than a million euro when implementing the MDR. Accordingly, not only medical experts are warning that patient care is in great danger.

After all, approximately 93% of medical technology companies are small- and medium-sized enterprises (SMEs) with fewer than 250 employees. “But if SMEs in particular are forced to relocate all of their development resources to regulation procedures and at the expense of innovation, it is obvious that the MDR has overshot the mark,” claims Dr Meinrad Lugan, CEO BVMed. This also means that development projects and innovations are being postponed or simply relocated to the US market, which is having a negative impact on prosperity.

Having said that, the medical technology sector is a key pillar of the industrial health economy (iGW) in Germany: it stabilises the economy, safeguards jobs, and encourages innovations. More than one-fifth of gross value added by the health economy is accounted for by the iGW. Strictly speaking, the medical technology sector stands directly for €15.5 billion gross value added and 235,000 jobs. When indirect and induced effects are included, the MedTech sector represents 450,000 employees and gross value added of €34 billion. The sector is a key driver of medical progress which entails intensive research efforts. On average, MedTech companies invest approximately 9% of their turnover in research and development. German medical technology is particularly successful on the international market, with exports in 2020 accounting for around 66%.

Since it came into force on 26 May 2021, MedTech companies, doctors and associations are in consensus that the MDR has evolved to become a major regulatory issue. The rules are not yet workable: the number and capacities of notified bodies is still too low. It is difficult to record clinical data on existing products. Innovations have been put on hold and are at risk of being relocated abroad. The issuing of 20,000 certificates by the end of the 2024 “grace period” is time-critical. But there is still no legal basis in place for remote audits and the regulations are not harmonized throughout the EU. There are no derogation procedures for “orphan devices” (niche products). The guidelines of the Medical Device Coordination Group (MDCG) are inconsistent and lacking in grace periods. The EUDAMED database (the European database for medical products in which economic players and official authorities are obliged to enter data) is not yet operative.

The German ARD production Plusminus also broadcast a piece in early August in which critical medical representatives voiced how medical care is deteriorating as a result of the new MDR.

The associations representing the medical products industry in Germany, Austria and Switzerland have presented a joint 10-point paper outlining the current problem areas in implementing the MDR while making proposals as to how they can be solved to safeguard the care of patients in the form of both innovative medical products and those which have proven their worth for many years. 

Pragmatic solutions need to be found for tried-and-tested existing products in particular, for example, using the “Acceptance of clinical practice” instrument.

For orphan devices, the European Commission should create derogation procedures in Europe in line with the US model of “Humanitarian Device Exemption” and the “Orphan Drug” regulations.

Special subsidy programs are to be applied for SMEs, for example, for supporting clinical studies, which are not only restricted to new developments and innovations but also include existing products.

Manufacturers of medical technology face the difficult task of being obliged to subject their products to extensive regulatory qualifications and submit comprehensive documentation prior to launching them onto the market and not just since introduction of the new EU MDR. This takes time and demands considerable know-how, as well as a partner availing of exactly this expertise.

At Actega, for example, there is a fixed contact person for each project who offers the corresponding service and specialist competence in the area of thermoplastic elastomer (TPE) materials and supports manufacturers and projects from development through to market launch. Extensive and comprehensive documentation is available for the ProvaMed TPE which guarantee compliance with the MDR as well as permit faster and better project success.

Comprehensive support is important because not only the products themselves but often each individual component also needs to meet complex requirements, such as proof of biocompatibility in line with USP Class VI or ISO 10993-5, for example. Biocompatibility means that the properties of the material used must be biologically compatible and should not display any undesirable interactions with other materials or living tissue.

Apart from the general requirement concerning the use of source materials comprising non-toxic substances, this requirement is subject to additional specification for substances which are carcinogenic, toxic to reproduction, and affecting the endocrinal system. Those manufacturers of medical technology relying on successfully tested, non-cytotoxic TPE synthetic granulates which can make an essential contributiontoward successful qualification are significantly facilitated in terms of tasks relating to conformity. The biocompatible ProvaMed TPEs have already been tested to ISO 10993-5, with outstanding results. And they are free of PVC and plasticisers. The use of TPE materials also helps manufacturers of medical technology to counter the increasing criticism of PVC and plasticisers as well as improve the safety of patients and specialist personnel.