Challenges of Medical Device Regulation for Small and Medium sized Enterprises

Abstract

AbstractFor known reasons, the European Parliament was forced not only to revise the old Medical Device Directive (MDD) and the Active Implantable Medical Devices Directive (AIMDD), but to replace it with the extensive MDR. With the implementation of the Medical Device Regulation (MDR) in May 2017, manufacturers of medical devices will face new challenges for their products in the future, which also have to be implemented in a timely manner. Particularly small and medium-sized enterprises (SMEs) are concerned about whether a timely adaptation to the MDR and their requirements can be implemented. The conversion is associated with a huge effort for all producers of medical devices and certainly, produkt launchers. The purpose of this paper is to get an overview of the most relevant and emerging requirements that manufacturers need to adapt to sell their medical devices in compliance with the MDR regulations. It also explains the extent to which changes and innovations in the MDR are discusses and problems for SMEs.