In a joint white paper on the further development of the European Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR), the two medtech industry associations BVMed and VDGH propose, among other things, the abolition of the five-year re-certification period and fast-track procedures for innovations, orphan devices and diagnostics.
"We need more transparency and efficiency, more predictability and speed, more international connectivity and competitiveness as well as good administrative practice," demanded the two CEOs Dr. Meinrad Lugan (BVMed) and Ulrich Schmid (VDGH) at a joint press conference. The comprehensive MDR/IVDR white paper with detailed proposals can be found at www.bvmed.de/whitepaper and www.vdgh.de/whitepaper.
According to BVMed and VDGH, the EU regulations MDR and IVDR, which regulate the marketing of medical devices and laboratory tests throughout Europe, are poorly crafted, too complicated and bureaucratic - and thus slow down innovation. There is a broad consensus that the MDR and IVDR are causing an undesirable shortage of products in medical care. A third of products are at risk of being withdrawn from the market, and many products are already no longer available on the market. Studies show: MedTech companies are forced to shift development resources to regulatory affairs in 65 percent of cases - at the expense of innovation activity. And 89 percent of medtech companies now prioritize US approval for their products, according to a study by the Boston Consulting Group. "We want a forward-looking reform that helps patients and Europe as a location for innovation - not continuous minor corrections," say Lugan and Schmid: "The two leading German medtech associations BVMed and VDGH have therefore drawn up a white paper with proposed solutions."
In addition to supplementing the current regulatory system, BVMed and VDGH advocate more predictability and transparency of processes, effective legal remedies against market access decisions, an improvement in international cooperation and a centralization of responsibility.
"We must act and further develop the structure of the MDR and IVDR. Our proposals are practice-oriented and have already proven their worth in other systems. Now is the right time to talk about them so that we can quickly take concrete action with the new Commission and the new Parliament after the European elections," said BVMed Managing Director Dr. Marc-Pierre Möll and VDGH Managing Director Dr. Martin Walger.
The joint BVMed and VDGH white paper proposes concrete solution options in five areas of action:
1. supplementing the current regulatory system
Fast-track procedures (accelerated procedures) analogous to other areas of law for
- innovative products
- Orphan devices and diagnostics for rare diseases
- Niche products with a proven track record
2. increase the efficiency of the system
Consistent implementation of the principles of good administrative practice through
- predictable deadlines and predictable costs of regulatory procedures
- Equal access for all to the regulatory system
- Increased transparency of certification processes, including through digitalization
- Effective legal remedies against market access decisions
- Better coordination of parallel and national legislation
3. reform of the five-year recertification cycle
- Abolish the limited validity period of certificates of five years
- More efficient and risk-based certification cycle based on post-market data
- IVDR: self-certification of low-risk products (class B) to reduce the burden on the system and eliminate bureaucratic reports with no patient benefit
4. improvement of international cooperation
- Restore the international reputation of the CE marking
- International harmonization of testing requirements (inclusion of the EU in the MDSAP program) for manufacturers' quality management systems
- Mutual Recognition Agreement (MRA) between the EU and Switzerland and the UK
5. centralization of responsibility
- Introduce a centralized accountable management structure
- Harmonize and centralize notification and monitoring of notified bodies across Europe
- Set up an SME office to support SMEs at EU level
"Together with all stakeholders, we want to make Europe a competitive MedTech location again and break up excessive structures and create good regulatory framework conditions - with courage and confidence. To this end, we call on the European institutions to enter into a structured dialog with us and all relevant stakeholders in Germany and Europe in order to take the necessary measures as quickly as possible," Möll and Walger concluded.
The 64-page white paper on the further development of the MDR and IVDR can be downloaded at www.bvmed.de/whitepaper and www.vdgh.de/whitepaper .
The German Medical Technology Association (BVMed) represents over 300 manufacturers, distributors and suppliers in the medical technology industry as well as providers of medical aids and homecare providers. The medical device industry employs over 250,000 people in Germany and invests around 9 percent of its turnover in research and development. The industry's total turnover is over 38 billion euros, with an export ratio of 67 percent. And 93 percent of medtech companies are SMEs. BVMed is the voice of the German medtech industry and, in particular, of medtech SMEs.
As a trade association, theAssociation of the Diagnostics Industry (VDGH) represents the interests of more than 120 companies operating in Germany with a total turnover of 6.8 billion euros in 2022. They manufacture examination systems and reagents for the diagnosis of human diseases, with which a turnover of more than 3.5 billion euros is generated, as well as instruments, reagents, test systems and consumables for research in the life sciences, with which a turnover of 3.3 billion euros is generated.
Media contact BVMed
Manfred C. Beeres | Head of Communications, Press Spokesman
beeres@bvmed.de | +49 172 615 7426 | www.bvmed.de
Media contact VDGH
Torsten Kiesner | Head of Press and Communications
kiesner@vdgh.de | +49 30 2005 99-43 | www.vdgh.de
