New Medical Devices Regulation: WKW Lecture with Matthias Scherer

Especially for small and medium-sized enterprises, the new Medical Devices Regulation of the European Union poses great challenges, as the legislator is making very high demands on documentation and quality management. There are differences depending on whether companies manufacture medical devices themselves, modify them, or only trade in products. The problem is that this often cannot be clearly categorized. As a result, companies are in acute danger of not operating in compliance with the law. Examples of this would be a hearing care professional who makes an earmold for a standard hearing aid, or an optician who “only” grinds a lens – are these considered manufacturers? What happens when a medical device is repackaged; which markings are then necessary? Who is allowed to manufacture custom products and what kind of documentation and market surveillance is required?

In order to answer these and other questions, to train companies and to point out the possible dangers, the Professional Group for Business Professions of the Vienna Chamber of Commerce invited interested parties to a lecture on December 13, which was attended by about 100 entrepreneurs. Due to the Corona situation, the event was broadcast online from a studio in the Haus der Wiener Wirtschaft. While attorney Katharina Raabe-Stuppnig spoke about the legal framework and possible penalties, Matthias Scherer as a regulatory affairs expert from the competence field Medical Engineering and Integrated Healthcare of the Faculty of Life Science Engineering at the University of Applied Sciences Technikum Wien related the topic to medical devices.

In the run-up to the event, meetings were held with representatives of the professional groups of opticians, contact lens opticians, hearing aid acousticians, orthopedic technicians and dental technicians in order to be able to address specific use cases in the presentation. It became apparent that small businesses urgently need support in the implementation of documentation requirements, as they often lack the time and knowledge to be able to implement legal requirements in their day-to-day business.

The almost three-hour presentation received very positive feedback and a large number of questions from the companies were answered. In order to be able to address individual problems of the different professional groups, guidelines will now be developed in the next step. These guidelines will be presented in workshops in spring 2022, and the entrepreneurs will then have another opportunity to ask their company-specific questions and discuss them with the experts. The overall goal is to help companies help themselves and show them how they can meet their legal obligations, in some cases by simple means.