The European legal framework for medical devices was altered by the Regulations on Medical Devices (Regulation (EU) 2017/745) and on In Vitro Diagnostic Devices (Regulation (EU) 2017/746) by introducing new responsibilities for EMA and national competent authorities in the assessment of specific categories of Medical Devices.
As of May 26, 2021, the Medical Devices Regulation is in effect. When launching new medical equipment onto the market, manufacturers are required to abide with the Regulation. Both the Medical Devices Directive 93/42/EEC and the Active Implantable Medical Devices Directive 90/385/EEC are repealed. As of May 26, 2022, the In Vitro Diagnostic Devices Regulation is in effect. It revokes the European Parliament and Council's Directive 98/79/EC on in vitro diagnostic medical devices.
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