EU: MDR-Medical Device Regulation – consolidated text

The consolidated final draft of the new Medical Device Regulation – MDR has recently been published. The new regulation shall replace the current medical device directives, namely
•    Medical Device Directive 93/42/EEC
•    Active Implantable Medical Devices 90/385/EEC

The IVD Directive 98/79/EC will be replaced by its own new regulation, namely In Vitro Diagnostic Medical Devices Regulation, IVDR.

The new regulation on medical devices brings many changes for medical device manufacturers with it, e.g. changes to the classification of some medical devices, unique device identification (UDI) for each product, etc.

It is expected that the final draft will be adopted by the end of this year. The new law comes into effect three years after publication in the EU Official Journal.

The consolidated text is available under: Medical Device Regulation (MDR)- latest text.

Do you need any assistance implementing the new requirements? Here you find lists of international consultants.