Beschreibung
Despite several amendments, the implementation of Regulation (EU) 2017/745 on medical devices (MDR) continues to result in product discontinuations and the outflow of innovation. The main reasons are
- excessive effort due to unnecessary ballast in the requirements,
- excessive costs that are not in proportion to the expected revenue from the products
- a lack of predictability and planning certainty when working with notified bodies.
The MDR particularly deprives small and medium-sized companies of the basis for an adequate business model. This position paper presents concrete and swiftly implementable proposals for solutions that primarily contribute to improved planning security and a reduction in the cost and administrative burden without jeopardizing the safety of patients and users. The individual points have been developed in collaboration with manufacturers and reflect their practical experience.
The position paper is also available in German.
Published in July 2024
