The implementation and impact of the medical device regulations (MDR) for (biophotonics) devices developed by research institutes in Europe: an update (Conference Presentation)

The introduction of the Medical Device Regulations within the EU in 2017 has made the certification of medical devices more challenging for research institutes especially providing clinical benefit. Information and guidance tools have been developed to support researchers. It is essential to prepare documentation during the development process related to quality control and risk assessments. To allow time for feasibility testing and improvements the device could be labelling as a ‘research only device’. After finalization of the design, a full clinical investigation, according to MDR, can be conducted. Recently, the EU authorities have acknowledged the negative impact of the MDR and measures are taken to relieve research institutes and promote health innovations again.