Together with the EU Commissioner, representatives from the regional medical technology industry as well as representatives from B. Braun and Aesculap discussed current issues and challenges in the Schwarzwald-Baar-Heuberg region. Taking part in the round of discussions were, among others, representatives from HEBUmedical, Henke-Sass, Wolf, Karl Storz, KLS Martin, Medical Mountains, MedTech Europe, as well as from the Ministry of Economic Affairs, Labour and Housing in Baden-Württemberg. Primary focus at the meeting was on the EU Medical Device Regulation and the new commission proposal for a health technology assessment (HTA).In his introductory words, Dr. Joachim Schulz, Chairman of the Board at the B. Braun subsidiary Aesculap, expressed his pleasure about the coming together of all participants. In the context of pending challenges, the cooperation of all parties and cohesion plays a pivotal role, which is why this was the perfect occasion to offer a platform for communication. “The implementation of the EU Medical Device Regulation (MDR) is a great challenge for the medical device industry,” said Schulz. Especially companies “with a comprehensive and heterogeneous product portfolio that has grown over decades – like Aesculap AG – are being especially challenged, as all registration documents and files on technical documentation must be sifted and reviewed.” Ultimately, this means a “significant amount of work and coordination” for the entire industry, according to Dr. Schulz.

For Dr. Andreas Schwab, it is therefore very important to establish “the necessary practical relevance” between legislation and industry. “I have been fighting for this for years. It is especially important for our region in which many successful medical device producers are located. An exchange between politicians and the industry is essential,” according to the European Representative – which is why he was all the more delighted that Vytenis Andriukaitis accepted his invitation.   

Vytenis Andriukatis, EU Commissioner for Health and Food Safety, was open to the impulses of the Tuttlingen-based companies. He is aware of the massive differences between the EU member states. For that reason it is especially important to create a transparent structure within which all states and companies have access to the market and information. The HTA is supposed to support players in medical technology and to help them reach a strong competitive position – both nationally and internationally.

Within the context of the MDR, present company representatives thematised on the one hand the issue of significant work effort and on the other hand the volatile comparability between member states and the associated “notified bodies”. These private inspection bodies are responsible for the certification of products, services, and procedures on behalf of the state. Delays and a lack of resources on their part would extend the processes substantially. Considering the fixed time constraints, this would constitute a noticeable bottleneck. Above all, smaller companies are being confronted by a disproportionate amount of work. In having to fulfill further requirements as a result of the HTA, research and production would be strained once again.      

Dr. Meinrad Lugan, Member of the Board at B. Braun Melsungen AG and moderator of this meeting, welcomed a harmonization of the standards within the EU by the HTA. However, he would prefer a volunteer approach: “The significant differences in reimbursement, the priorities in health care, as well as treatment pathways in the member states are a key argument for encouraging the HTA cooperation on a voluntary basis and not, as suggested in the commission proposal, subjecting medical devices Europe-wide to an obligatory clinical assessment.”