CAMD and MDR/IVDR transitional provisions
The EU Competent Authorities for Medical Devices (CAMD) is the platform which assembles the national competent authorities for medical devices in Europe. The main objective of CAMD is to improve cooperative efforts, enhance post-market surveillance and boost communication in the medical device sector across the European Union.
One of CAMD’s most recent initiatives concerns the communication about and implementation of the new Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR). Aiming to provide guidance and clarity, the CAMD group published two FAQ documents about the transitional provisions set out in the regulations. The main topics covered in the publications are:
· Placing MDR/IVDR compliant devices on the EU market before the MDR/IVDR date of application
· Placing MDD/IVDD/AIMD compliant devices on the EU market after the MDR/IVDR date of application
· Sell off provision
The Medical Device Regulation, which will replace the Medical Device Directive (93/42/EEC) and Active Implantable Device Directive (90/385/EEC), has entered into force on 26 May 2017. The regulation will, however, become fully applicable from 26 May 2020 (i.e., the date of application). This gives manufacturers, notified bodies, authorities and all other actors concerned a transition period of three years during which the MDR will apply in parallel with the current medical device directive. Keeping in mind some exceptions, the directives 93/42/EEC and 90/385/EEC will be repealed after the date of application.
Different from the MDR, the In Vitro Diagnostics Regulation will become fully applicable from 26 May 2022. Therefore, the transitional period during which the IVDR and In Vitro Diagnostics Directive (98/79/EEC) will coexist is 5 years. From 26 May 2022, the Directive 98/79/EEC will cease to apply. Exceptions to this date of application include for instance the UDI labelling and provisions for Notified Bodies and European Union reference laboratories.
If you wish to know more about the new Medical Device Regulation and In Vitro Diagnostics Regulation, please do not hesitate to contact us. With more than 30 years of regulatory experience, Obelis experts will gladly assist you.
Hannah Van Deun