Stakeholders request revision of the regulation
Patient safety is top priority in medicine and biomedical engineering. Aiming to increase patient safety, the EU introduced the European Medical Device Regulation (MDR) in 2017. During a conference organized by the Fraunhofer High-Performance Center Translational Biomedical Engineering being part of the Fraunhofer Institute for Toxicology and Experimental Medicine ITEM, experts, representatives from small and medium enterprises, the chairmen of the boards of directors of the academic umbrella organization DGBMT and the industry association BVMed, and representatives from acatech and the VDE Society Microelectronics, Microsystems and Precision Engineering (GMM) discussed challenges and consequences of the MDR. They are expecting massive negative consequences from the regulation and are suggesting specific measures for a revision of the MDR.
The conference started with a presentation of first results from a market survey performed by deloitte, mdr-competence and Fraunhofer, providing an idea of the current opinion and appraisal of foreseeable consequences of the MDR. “Introduced with the aim of increasing patient safety, the MDR in its present form shows massive negative effects”, says Prof. Theodor Doll, Head of the Fraunhofer High-Performance Center. “Consequences include on the one hand a gradual development of non-assured patient supply with existing products, given that these are partly being withdrawn from the market, as they would require re-evaluation in clinical trials, and on the other hand an already manifest inhibition of innovation due to excessive entry barriers in the EU.”
Based on the currently available data, the study further differentiates previous assessments by the industry associations Spectaris and BVMed, with the same tenor:
Only 15% of manufacturers feel sufficiently informed about implementation of the MDR.
40% of manufacturers will withdraw existing medical devices from the market.
50% reckon that products or product lines will have to be terminated because of the increased requirements.
Over 40% expect significantly increasing product prices.
65% of companies feel compelled to shift resources from development to regulatory issues – at the expense of innovation efforts.
70% of companies are feeling uncertain as to whether the notified bodies that have assisted them so far will continue to do so to allow all deadlines to be met.
The consequences for the biomedical engineering sector in Germany and Europe are huge: “The figures make it quite clear that in the medium term the regulation will result in migration towards the FDA-regulated American market and depletion of the innovation hotspot Germany,” explains Prof. Doll.
Key factor in the economy and job market
The major innovation driver in this sector are small and medium-sized enterprises (SMEs), accounting for 93 percent of all medtech companies. These, however, are particularly affected by the negative effects of the MDR, facing challenges that they can hardly manage. “Development costs and time will substantially increase, leading to markedly deteriorating prospects of start-ups and SMEs in this sector,” says Prof. Thomas Lenarz, chairman of the Board of Directors of DGBMT. “Likewise, it will become much less attractive for investors to invest in innovative medtech developments.”
Joint proposal for MDR optimization
Based on the market survey performed, representatives from industry, associations and academia are suggesting specific measures that could both relieve the current situation and restore confidence in the innovation hotbed Germany for the future. These include:
• Accelerated accreditation of notified bodies:
The accreditation of notified bodies – publicly controlled, non-government testing facilities that assist and supervise medical device manufacturers – must be restored as soon as possible, so that they can resume their work. To accelerate the accreditation of notified bodies, the EU must considerably enhance staffing of the Joint Assessment Teams (JAT), to guarantee the capacity to act of the notified bodies in their actual role as reliable service providers to medical device manufacturers with the foreseeable volume of work.
• Correction of deadlines for manufacturers:
Manufacturers of medical devices are directly dependent on the capacity to act of the notified bodies. Because of their delayed accreditation, manufacturers are unable to meet the current deadlines including transition periods, so that these have to be rescheduled – starting from the renomination (i.e. capacity to act) of the then available notified bodies. A moderate and reasonable period of time would be at least 2.5 years from this date on, to avoid threatening the existence of manufacturers through no fault of their own, but simply as a result of the still limited capacities (as is foreseeable) of the notified bodies.
• Development of implementation guides:
To put start-ups, very small companies (up to 25 employees) and SMEs in a position to survive in the international competition, a consulting and support program is necessary that will enable them to continue to develop medical devices in the future. Such a program could be similar to the EU REACH corrections that became effective in 2013.
• Continuation of subsidies:
The successful funding of the “innovation driver biomedical engineering” in the past years should be prolonged or extended in view of the situation caused by the MDR, to prevent an innovation slump and migration to other markets. This should also include fast development of novel testing methods, exchange of data between companies, and subsidies for cost-intensive first clinical phases.
• Special regulations for conformity assessment:
The MDR should be enhanced with special (fast-track) provisions for conformity assessment of highly innovative products addressing rare diseases or applications, to enable their quick market entry.
• Focus on “special groups”:
Medical devices for infants, children and other special groups are already being neglected by the healthcare industry, because the ratio of development costs to return on investment is a critical issue in these small market segments. An improved MDR should not further aggravate this situation, but rather counteract in order to improve the supply situation for these groups of patients as well.
• Prevention of unreasonable consequences for already established products:
In particular those products that have been on the market for several decades already with only very few “undesirable incidents” must not be kicked out of the market – and patient supply thus endangered – by an undifferentiated request for performance of “clinical re-evaluation/re-testing”.
• Avoidance of trust-like structures:
Single institutions in the biomedical engineering sector must not act as contract testing facility, notified body, national consultant, consultant to the EU legislative bodies, and accredited training institution at the same time. The FDA regulations, restricting the role of vertical, trust-like structures, may serve as a first model here.
The above mentioned stakeholders have now proposed these measures to the German Federal Ministry of Health.
Dr. Cathrin Nastevska
Phone +49 511 5350-225
contact for scientific information:
Prof. Dr. Theodor Doll
Phone +49 511 5350 248