Clinical Evaluation Requirements – From MEDDEV to MDR

The new Regulation consolidates two existing legal provisions and replaces both the MDD and the Active Implantable Medical Device Directive (AIMMD 90/385/EEC).

It is a fundamental revision of the Directives and is intended to establish a robust, transparent, predictable and sustainable regulatory framework for medical devices, which ensures a high level of safety whilst supporting innovation.

It was triggered by the breast implants scandal (as well as other high risk events) where these implants had been approved but had very little safety and clinical evidence associated with them.