Europe – IVDR Watch: European regulators update SSCP rules, high-priority implementation actions and technical documentation guidelines

Medical device manufacturers doing business in Europe should take note of a number of updates affecting in-vitro diagnostic (IVD) medical device regulations set to take effect in 2022.

First, the Medical Device Coordination Group (MDCG) has updated guidance regarding how manufacturers must draw up a summary of safety and clinical performance (SSCP) for implantable devices and class III devices.

Second, European Commissioners issued updates to their implementation plans for the In-Vitro Diagnostic Medical Devices Regulation (IVDR) with new guidance on the Joint Implementation Plan for the IVDR…