Problems associated with MDR implementation endangers MedTech innovations

Thu, 2019 / 10 / 17
The new medical device regulation (EU) 2017/745 (MDR) came into action in May 2017 and replaced the Medical Device Directive (93/42/EWG) as well as the Active Implantable Medical Devices Directive 90/385/EEC as both regulations were now combined in a single directive. The new MDR includes significant changes to the market entry process of medical devices, with emphasis on the mechanisms and the assessment of high-risk products. To ensure a smooth transition, a three-year transitional period was established until complete adaptation of the new MDR, and further transitional aspects have been defined for existing permissions for available medical devices.

Despite the transitional period and the implementation more than two years ago, increased concerns are rising regarding possible bottlenecks in the supply of medical devices, particularly devices utilized in invasive surgeries. To overcome these bottlenecks, the medical devices manufacturers and industry associations demanded longer transitional periods in order to be able to cope with the increasing regulatory requirements in the certification process. With rising possibilities of supply bottlenecks, the German federal government shares the concerns of the medical devices manufacturers and supports longer transitional periods in order to avoid supply shortage.

Besides the increased regulatory requirements within the new MDR for device manufactures, other factors may contribute to the creation of supply bottleneck. The emphasis on increasing requirements for conformity assessment and post-market surveillance originated from the scandals of damaged breast implants with industrial silicon and hip protheses with metal abrasion which were certified by the notified bodies, who have failed to detect the existing quality deviation. As a result, notified bodies also face higher regulations and supervision by national authorities. Once the transitional period of the MDR ends on May 26, 2020, all currently active notified bodies will automatically lose their accreditation and must apply for new designation. A significant drop of the available notified bodies could be assumed.

Within the expiring directives, the medical device manufacturers had a choice of 58 different authorized notified bodies, however, only five inspection bodies are certified so far to perform a conformity assessment based on the new MDR standards. This could create a bottleneck in the certification process of new medical products and lead to a to significant supply shortage. A survey performed by the German Electrical and Electronic Manufacturers' Association (ZVEI) showed that 70% of companies, who are represented within the association are concerning difficulties in cooperating with selected notified bodies and complain about delays in the conformity assessment. Existing shortage of specialists also contribute to the delaying as medical device manufactures and notified bodies face a competition about the same skilled workers.

Currently, the medical devices manufacturers are hoping for an extension of the transitional period in order to have enough time to adapt to the new procedures included in the conformity assessment to avoid difficulties in planning for the introduction of new medical devices. For a smooth market introduction of new medical devices, it is now critical to carefully evaluate the aspects of CE certification, reimbursement options and market access at an early stage while considering possible risks.

By Dipl.-Kffr. Heike Kielhorn-Schönermark and M. Sc. Maximilian C. Florian

Sources (German only):
Ärzteblatt: Medizinprodukteverordnung: Industrie will längere Übergangsfristen
Ärzteblatt: Bundesregierung hält Engpässe bei Medizinprodukten für möglich
DeviceMed: Zwei von 58 sind viel zu wenig
Tüv Süd: MDR: EU-Medizinprodukteverordnung
Klinik Einkauf: Veränderungen an EU-Medizinprodukte-Verordnung unwahrscheinlich

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