MedTech associations BVMed and VDGH are calling for the abolition of re-certification and fast-track procedures for innovations
29.08.2023 11:49
In a joint white paper on the further development of the European Medical Devices 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 Innovations and orphan devices as well as 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 chairmen of the board, Dr. Meinrad Lugan (BVMed) and Ulrich Schmid (VDGH) at a joint press conference.
The EU regulations MDR and IVDR, which regulate the marketing of medical devices and laboratory tests across Europe, are poorly crafted, too complicated and bureaucratic - and thus slow down innovation, according to BVMed and VDGH. There is broad consensus that MDR and IVDR are causing an undesirable shortage of products in medical care. A third of the products are in danger of being withdrawn from the market, and many products are already no longer available on the market.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 regulation in 65 percent of cases - at the expense of innovation activity. And 89 percent of MedTech companies now prioritize US approval of 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 constant small-small corrections,” say Lugan and Schmid: “The two leading German MedTech associations BVMed and VDGH have therefore drawn up a white paper with suggested solutions. “
In addition to complementing the current regulatory system, BVMed and VDGH are committed to greater predictability and transparency of processes, effective legal remedies against market access decisions, improving international cooperation and centralizing responsibility.
“We have to act and further develop MDR and IVDR structurally. Our suggestions are practice-oriented and have already proven themselves in other systems. Now is the right time to talk about it so that after the European elections we can quickly take action with the new Commission and the new Parliament,” said BVMed Managing Director Dr. Marc-Pierre Möll and VDGH managing director Dr. Martin Walger.
The joint white paper from BVMed and VDGH suggests concrete solution options in five areas of action:
1. Complement 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. Increasing the efficiency of the system
Consistent implementation of the principles of good administrative practice
- predictable deadlines and calculable costs of the regulatory procedures
- equal access for everyone to the regulatory system
- Increased transparency of the certification processes also through digitalization
- effective legal remedies against market access decisions
- better coordination of parallel and national legislations
3. Reform of the five-year recertification cycle
- abolish the limited validity period of five years for certificates
- more efficient and more 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 without patient benefit
4. Improving 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
- Agreement on the mutual recognition of admission conditions (Mutual Recognition Agreement, MRA) between the EU and Switzerland and the UK
5. Centralization of responsibility
- Establish a central, accountable management structure
- Harmonize and centralize notification and monitoring of notified bodies across Europe
- Establish an SME office to support SMEs at EU level
“Together with everyone involved, 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 dialogue with us and all relevant actors in Germany and Europe in order to take the necessary measures as quickly as possible,” said Möll and Walger’s final appeal.
The 64-page white paper on MDR and IVDR further development is available at www.bvmed.de/whitepaper as well as www.vdgh.de/whitepaper be downloaded.