Tuttlingen/Brussels – The focus was on the implementation of the European Medical Devices Regulation (MDR): MedicalMountains GmbH attended a meeting with members of the European Parliament and the EU Commission in Brussels on Tuesday at the invitation of the Bavarian Representation to the European Union. "The urgency of the problem has arrived," sums up Managing Director Julia Steckeler afterwards.
Together with representatives of associations, companies, clinics, notified bodies as well as state and federal politics, MedicalMountains Managing Director Julia Steckeler and Corinna Mutter from SPECTARIS explained what difficulties arise with the MDR implementation, what the consequences are - but above all with which solutions the situation can be improved.
“Medical devices are withdrawn from the market because the cost of re-certification is too high. Those who still want to take the step have to contend with capacity bottlenecks at notified bodies. Innovation projects are put on hold or canceled altogether. We clearly presented these effects again at the meeting,” says Julia Steckeler, summarizing the difficulties. An emotional exchange developed around the topics. The messages from users, from doctors, were particularly alarming. "The urgency of the problem has reached the EU Commission," states Julia Steckeler. Accordingly, all levers will continue to be set in motion to move forward now, not just in two years. Suggested solutions were discussed as starting points, which were presented as part of the most recent industry survey by MedicalMountains GmbH, the SPECTARIS industry association and the German Chambers of Industry and Commerce (DIHK).
Bavaria's Health Minister Klaus Holetschek then also advocated swift action. "Patient protection is a valuable asset - and the Medical Devices Ordinance makes sense, of course. But it also creates some problems in implementation. The EU Commission must take countermeasures quickly here,” he is quoted as saying in a statement published by the Bavarian State Ministry of Health and Care. Holetschek named the appointment of further notified bodies, an exemption for niche products and a solution for existing products that could not make the transition to the MDR due to existing capacity bottlenecks at the notified bodies as essential necessary steps. Prior to this, the Baden-Württemberg Minister of State, Florian Stegmann, had already sent a “fire letter” to Karl Lauterbach asking him to advocate for improvements at the meeting of EU health ministers (EPSCO), which was taking place at the same time. According to reports, representatives of several EU countries expressed their concern about the difficulties with the MDR.
Julia Steckeler sees the fact that Bavaria and Baden-Württemberg are pulling together in Brussels as a “strong sign”. Likewise, that more and more EU states are calling for further steps towards a practical MDR to be taken. The regulation is not the sole problem of two federal states, not just Germany. "It affects the care and safety of patients throughout Europe," emphasizes the MedicalMountains Managing Director.
