Medical Technology Committees

Industry Day is the trade association’s annual general meeting. It serves as the most important forum for exchange among our members’ senior leadership. In addition to the presentation of an annual report and updates on current topics and projects supported by the trade association, new market figures are also presented. Industry Day makes strategic decisions that serve as guidelines for the Executive Board of the Medical Technology Trade Association. Every three years, the trade association’s Executive Board is elected at the Industry Day. In a second, typically public session, the Industry Day addresses current challenges facing the industry. External speakers are regularly invited for this purpose. Participating in the Industry Day facilitates networking with industry colleagues and provides an opportunity to discuss current topics and market developments. Keynote presentations on relevant topics provide inspiration and thought-provoking ideas for implementation within one’s own company. Furthermore, participants have a direct influence on the strategic direction of the association, not least through the election of the Executive Board. 

The digitization of processes and documents—to demonstrate product compliance throughout the entire lifecycle and to significantly streamline quality management (QM) and regulatory affairs (RA) processes through electronic solutions—is becoming increasingly important as a way to save time, money, and, above all, scarce human resources within companies. The Digitization Working Group is addressing this important issue for the future.

The focus is on the regular exchange of information regarding how medtech companies are transitioning from paper-based systems to digital solutions and processes. The goal is to transparently present solutions already available on the market and discuss their benefits. In addition, there will be close collaboration with MDKU e.V. to advance the standardization of a uniform digital data model for the content of technical documentation for medical devices and to promote its acceptance by regulatory authorities and Notified Bodies.

In the working group, members discuss current cross-cutting challenges related to hygiene regulations and the reprocessing of medical devices, as well as recent legal and scientific developments, such as new reprocessing methods.

Within the International Market Access Working Group, SPECTARIS members discuss a wide range of market access conditions for medical devices on the global market. The group has its roots in the ASEAN Project Group, which had primarily focused on the ASEAN economic region. As it became clear over time that this regulatory exchange was also necessary with regard to other international markets, the International Market Access Working Group now addresses regulatory challenges worldwide.

The Circular Economy Working Group is a cross-association working group in which our members are kept informed about current developments in regulatory requirements under the Circular Economy Action Plan. Key topics include the Battery, Packaging, and Ecodesign Regulations, the WEEE Directive, and the Green Claims Directive. In addition, members are welcome to use this forum to discuss the practical implementation of circular economy regulations, as well as to share concerns or issues.

This is a cross-association working group in which AI-related topics can be examined and discussed from both a regulatory and a practical perspective.

With the entry into force of EU Regulation 2017/745/EU on medical devices (Medical Device Regulation—MDR), the framework conditions for placing medical devices and their accessories on the market have changed. The MDR Working Group monitors and actively contributes to current developments at the European and national levels regarding the implementation and further development of the EU regulation. Thanks to the active participation of some MDR Working Group members in various working groups at the European level, there is a regular exchange of information. Specific issues related to the MDR are discussed and addressed in depth in separate task forces.

The working group focuses on preparing political and strategic communications regarding issues and projects relevant to medical technology. The working group is composed primarily of public and government affairs experts from the member companies. The working group meets at irregular intervals, particularly, of course, in the run-up to and following elections.

The Substance Regulation Working Group is a cross-association body that addresses all aspects of chemicals legislation and the regulation of substances that are relevant to the members. The members address topics such as REACH, CLP, RoHS, and other relevant regulations. During the meetings, current developments in chemical legislation are highlighted, practical implementation issues are discussed, and potential solutions are explored. External experts may be invited to provide in-depth analysis of specific topics. Between meetings, members receive regular updates on legislative changes and have the opportunity to raise their concerns and issues regarding chemical regulation.

Twice a year, regulatory affairs experts from member companies meet as part of the Medical Technology Regulatory Affairs Forum. At these meetings, they receive updates on and discuss current topics such as the new Medical Device Regulation, as well as other issues related to national and international medical device legislation. Topics deemed particularly important by the members are explored in greater depth during the meetings with external speakers. Between meetings, members regularly receive up-to-date information on regulatory developments in the medical technology sector and have the opportunity to provide input on specific legislative measures and current issues.

The Defense, Civil Protection, and Disaster Management Working Group connects the medtech sector with policymakers, government agencies, and aid organizations, and focuses on concrete, dual-use solutions such as mobile medical units, telemedicine and robotics, and secure IT and resilience.