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Deutsche Krankenhausgesellschaft e.V. Mr. Peep Peterson German Hospital Federation Minister of Health Wegelystraße 3 10623 Berlin Council of the European Union Germany Rue de la Loi 155 Andrea Hauser (solicitor) LL.M. Residence Palace Advisor, legal department 1040 Brussels [email protected] Belgium Tel.: (+49)30 39801-1421 Fax: (+49)30 39801-3410 by Mail: [email protected] Berlin, 2022-11-24 Supply bottlenecks and deterioration of patient care due to Medical Device Regulation (MDR) - Legislative action needed - EU Council of Health Ministers on December 8th (EPSCO) Dear Minister Peterson, with this letter, the professional medical societies and hospitals from Germany ask you as a matter of urgency in the near future to support legislative solutions to mitigate the implementation problems caused by the EU Medical Device Regulation (MDR) in the upcoming EU Council of Health Ministers on December 8th. The renewed EU directive on medical device regulation was initiated with the aim of improving patient safety. Already during the protracted negotiations, a wide variety of stakeholders pointed out the potential negative consequences for supply chain throughout the process, unfortunately without success. The MDR is now in force and has been subject to more intense criticism because it has not brought an improvement in patient safety. Instead, it put some patients at risk. The complex requirements are in some cases difficult or even impossible to implement, and there is growing concern that the negative developments for medical care in Germany and throughout Europe that are already becoming apparent will continue to worsen and become much more visible in 2023. We received reports from physicians and hospitals that patients can no longer be adequately cared for. Already reported are delivery delays, current bottlenecks, assortment streamlining and product discontinuations. Purchasers are trying to counter these developments by stockpiling large quantities. However, this attempt will only postpone the recognisability of the problem. Furthermore, it is also reported that in some cases problems have already occurred in patient care, because for example the supply of certain instruments has been discontinued at short notice, which has impaired interventions and surgical processes. In some areas there are adequate replacement products, in other areas there are only inferior quality substitutes available, or there are no alternatives at all. Other products are only available in certain sizes, which means they do not fit properly. This topic is particularly virulent in the area of ‘niche products’ which, although only needed for small populations of patients, but are essential for their medical care. If such products are no longer available, or are only available in certain sizes or of inferior quality, patients can in some cases no longer be treated to the usual standard. This means a medical step backwards for several decades. These difficulties are due to the fundamental changes in market access criteria following the entry into force of the MDR, the need for re-certification of all medical devices, the unclear rules for conducting clinical trials even for existing devices that have been tried and tested for many years, and a fundamental lack of provision of the necessary infrastructure in the form of a sufficient number of Notified Bodies. For the manufacturers, the redefined requirements mean an increasing level of administrative efforts and require significantly more human resources. As a consequence, they lead to high costs and ultimately greater market adjustments. Unfortunately, the personnel factor in particular is often disregarded when establishing new additional requirements and bureaucracy. There is a massive shortage of skilled workers in the healthcare sector anyway, and it is imperative to counteract this. Other factors to be considered are the standstill of medical innovations at many manufacturers, since personnel capacities are extensively tied up by the MDR, as well as the feared shift of approvals of innovations to other markets (USA, Asia, etc.), for which no regulations comparable to the MDR exist. For Germany as a high-tech medical location as well as for other locations within Europe, this is a profound cut. Even if the extent of the consequences cannot yet be fully assessed today, the scope and intensity of the cases and concerns expressed show, with a view to the future, that the difficulties inherent in the MDR must be taken into account in order to ensure the safety of patient care and the innovative strength of medical device manufacturers to develop new, safe medical devices. The solution mechanisms (Art. 59 - derogation from the conformity assessment procedures, special approval of niche products; implementing act according to Art. 59 (3); etc.), which are included in the MDR and have been discussed many times, do not take the problem into account. They are, if at all, only conceivable for absolute individual cases. It remains to be seen whether a procedure as described in Art. 97 MDR is suitable to solve or at least reduce the problems. Insofar we appreciate that the European Parliament, the Council of the European Union and the European Commission are addressing the concerns of medical professions and hospitals. At the EPSCO Council meeting on June 14, 2022, member states have already discussed the problems, and EU Health Commissioner Stella Kyriakides has called the certification backlog a concern (status of certifications in June: about 1,000 products certified; 24,000 products not yet certified). The German Federal Minister of Health, Prof. Karl Lauterbach, also explicitly addressed the Health Commissioner in a ministerial letter dated July 18, 2022, stating that it is urgently necessary to take further actions. These would have to be sustainable and enshrined in European medical device law. Considering all these political developments, the Medical Device Coordination Group (MDCG) chaired by the European Commission has approved a list of measures to resolve the implementation problems. Despite the fact that such documents have no binding effect and the interpretations made therein may be helpful, they are not able to solve the problem in its entirety. As a result, it can be stated that the MDR is causing profound problems. We are therefore currently urging all EU health ministers not to wait until the expiry of the transitional periods in May 2024 to determine that supply shortages have arisen. Rather, legislative action to amend the MDR must be taken now to avoid jeopardizing medical care. Medical device manufacturers are currently preparing or have already prepared their business plans and budgets for 2023. If regulatory easements are not made immediately, a significant number of products will disappear from the German and thus also from the European market. We would be grateful for your support! Yours sincerely Prof. Dr. Jörg Dötsch President The German Society of Pediatrics and Adolescent Medicine (DGKJ) Prof. Dr. Dominik Schneider Representative of pediatric specialties, Member of the executive board, conference president 2022 The German Society of Pediatrics and Adolescent Medicine (DGKJ) Prof. Dr. med. Ernst Klar Chair of the DGCH-Project Team Medical Devices German Society of Surgery (DGCH) Prof. Dr. Dr. Andreas Markewitz Secretary German Society for Thorax, Cardiac and Vascular Surgery (DGTHG) Dr. med. Ludger Tüshaus German Society for Pediatric Surgery (DGKCH) Prof. Dr. med. Matthias Gorenflo President German Society for Pediatric Cardiology and Congenital Heart Disease (DGPK) Prof. Dr. Benedikt Friemert President German Society for Orthopaedics and Trauma (DGOU) German Trauma Society (DGU) Prof. Dr. Bernd Kladny General Secretary German Society for Orthopaedics and Trauma (DGOU) Prof. Dr. Dietmar Pennig General Secretary German Trauma Society (DGU) Prof. Dr. Andreas M. Halder President German Society for Orthopaedics & Orthopaedic Surgery (DGOOC) Dr. Gerald Gaß Chairman of the Board German Hospital Federation (DKG) Saatja: Selke, Anja <[email protected]> Saadetud: 25.11.2022 11:40 Adressaat: SM Info <[email protected]> Teema: Deterioration of patient care due to Medical Device Regulation (MDR) - EPSCO meeting on December 8th Dear Minister Peterson, please find attached our letter on the above-mentioned subject with the request for your support. Identical copies of the letter have been sent to all EU Health Ministers. Kind regards Andrea Hauser (solicitor) LL.M. Advisor, legal department German Hospital FederationWegelystraße 3 | 10623 Berlin | Germany Telefon: &#43;49 30 39801-1421 Telefax: &#43;49 30 39801-3410 E-Mail: Website: