OBJECTIVES: The Medical Device Regulation (MDR) has been criticised based upon the presumption that it may detrimentally affect the access to implantable and class III medical devices (MDs) because it probably will cause significant price increase. It has also been claimed that the stringent regulatory requirements to prove the conformity of such MDs create unduly high entry barrier for new products that are developed by small manufacturers. The probability of these future expectations has been evaluated.

METHODS: Unstructured interviews were conducted with the management of manufacturers of various sizes (n=25) who are selling in the EU to understand their future expectations. Registries and other databases were also searched for supplementary information.

RESULTS: The interviewees had unanimous opinion on that MDR may significantly limit the small manufacturers to develop their product pipeline because the conformity of the new MDs shall be justified in costly clinical investigations, unless the equivalence of the devices is duly justified by the access to the technical documentation of the original device. This provision provides an unprecedented legal instrument to limit the market entry of generic MDs even before and after the expiry of the patent protection of the original devices. Hence, there was also agreement on that the increased regulatory entry barrier for new MDs may foster the market concentration in this segment. Nevertheless, this would be beneficial for the manufacturers of original devices because it supported them to make better return on their R&D investment.

CONCLUSIONS: The findings suggest that MDR may facilitate the dropout of small generic manufacturers from the EU market, while it supports the development of innovative MDs by large manufacturers. This may lead indeed to price increase and it also seems probable that the MDR will increase the gap between Western and Eastern Europe in terms of access to modern implantable and class III MDs.