Supporting the introduction of specialised, low-risk medical devices into clinical practice in Europe

Medical devices intended for small patient populations have difficulty entering the market because they are commercially less attractive, and stricter Medical Device Regulation (MDR) adds barriers. This study aimed to analyse the opinions of professionals working with MDR in the Netherlands regarding the feasibility of offering such medical devices via open-source and shared in-house development routes.

Interviews were conducted with 10 participants. Three cases of class I medical devices were presented with a proposed route and two questions: Who is the legal manufacturer? Which MDR documentation is minimally required?. The answers were interpreted using the MDR.

For all cases, the suggested routes were deemed feasible, but the participants did not reach a consensus on the research questions. The MDR lacks clarity on the position of the legal manufacturer for open-source medical devices made by patients themselves and on the transfer of designs and documentation of in-house developments for non-commercial purposes.

Offering low-risk medical devices via open-source or shared in-house routes should be carefully explored on a case-to-case basis. Preconditions to consider are meeting the orphan medical device criterion, an inherent low-risk profile, and validation of processes by skilled professionals.