Medical Device & IVD regulations, impacts for MD manufacturers

The origin of the proposed regulations dates back to 2008: The Medical Device Regulation and the In Vitro Diagnostics Regulation were initially proposed in 2008 when the EU commission triggered a consultation on the community’s existing requirements covering medical devices. The plan was first released by the European commission in 2012 to modify the EU’s medical device regulatory framework along with a proposed regulation replacing the EU’s current medical device directive (93/42/EEC), the EU’s directive on active implantable medical device (90/385/EEC), and the In Vitro Diagnostic directive 98/79/EEC.

The final publication for both regulations is expected for no later than May 2017. The manufacturers will phase out from the respective directives governing their currently approved medical devices through a transition period of three years and fully embrace the requirements of the MDR, which will take full effect in 2020.The same is expected for In Vitro Diagnostic Medical Device Manufacturers with a transition period of 5 years, and the IVDR becoming enforceable by the end of 2022.