In April 2017, the European Parliament and the Council adopted the Medical Devices Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR).
These two Regulations create a robust, transparent and sustainable regulatory framework, recognised internationally, which improves clinical safety and creates fair market access
The MDR replaced the Medical Devices Directive 93/42/EEC (MDD) and the Active Implantable Medical Devices Directive 90/385/EEC (AIMDD). The MDR became applicable on 26 May 2021.
The IVDR replaced the In Vitro Diagnostic Medical Devices Directive (98/79/EC) (IVDD).
The IVDR became applicable on 26 May 2022…