The Medical Device ecosystem is still regulated by three Directives adopted in the 90s (namely, 90/385/EEC, 93/42/EEC, 98/79/EC). Now, expectations are changed, technologies are advanced. Therefore the European Commission proposed a comprehensive revision of the framework, which is currently in the final stage of negotiations in trilogue between the Commission, Parliament and Member States.
According to how broad the definition of “medical devices” or “in-vitro medical devices” is going to be, medical health apps could potentially be included in the scope of legislation. We believe that small developers and digital businesses would be negatively impacted: new burdens, heavy certification processes and paperwork will indeed hamper innovation.
We are collaborating with GSMA, Continua Alliance and MedTech and asking the Council and European Parliament to support and maintain the definitions of medical devices as included in the Council’s Partial General Approach on the proposed Regulation on medical devices and the proposed Regulation on IVDs.