Since 26 May 2021, the EU Regulation 2017/745 - MDR has to be implemented EU wide in the MedTech sector. The directive regulates the placing on the market, making available on the market and putting into service of medical devices and their accessories and directly affects many local companies. Compared to the old Council Directive 93/42 - MDD, requirements have been tightened and additional obligations imposed on the affected parties. The aim of the EU legislation was and is to increase transparency in the medical technology sector and to improve the protection of the health and safety of patients. Whether this goal can be achieved remains to be seen. At the moment, in any case, product portfolios are being strategically re-evaluated by SMEs as well as by the big players, especially with regard to the profitability of small to medium-sized volumes. In this context, an extremely challenging time has dawned for medical technology companies. Many open regulatory questions and especially the expense of furnishing proof are increasingly burdening affected companies. In order to achieve legal certainty for regulatory compliance, we would be pleased to assist you. As an full service #IP law firm with offices in Tuttlingen, Munich, Hamburg and Zurich, among others, and having inter alia a focus on medical technology, we recently had our regulatory expertise certified by TÜV SÜD with regard to the new MDR. This means that we can now be designated as the Person responsible for regulatory compliance under Art. 15 MDR - PRRC by small and micro enterprises, among others, and thus be externally responsible for all regulatory matters relating to the MDR. With our other services, in particular all matters around patents, trademarks and designs, we assist you not only in regulatory aspects but also in all matters of intellectual property.
Full service with the mind on what really matters – this is Stolmár & Partner.