The currently applicable Medical Device Directive will be repealed by the Medical Device Regulation (MDR) on the 26th of May 2021.
In-Vitro Diagnostics devices are regulated by the In Vitro Diagnostic Devices Directive. This Directive will be repealed by the In-Vitro Diagnostic Devices Regulation (IVDR) on the 26th of May 2022.
One of the requirements set out in the MDR and IVDR is that the device needs to be registered to the European database on medical devices - EUDAMED.
EUDAMED consists of 6 modules, which are not yet fully functional:
1. Actors registration
2. UDI/Devices registration
3. Notified Bodies and Certificates
4. Clinical Investigations and performance studies
5. Vigilance and post-market surveillance
6. Market Surveillance
From December 2020, EUDAMED Actor registration is possible.
From September 2021, second and third module of EUDAMED will become active (UDI/device registration & module on Certificates and Notified Bodies)
Other modules (on vigilance, clinical investigations, etc.) will be displayed later on, as soon as they are functional.
Full functionality of EUDAMED is envisaged for May 2022.
Until EUDAMED is functional, medical devices are still to be notified to the relevant EU Member States’ Competent Authority.
Do not forget that the UK has officially left the EU!
EUDAMED Registration is not relevant for the devices that are to be placed on the UK market, however there is a mandatory registration to the UK Competent Authority MHRA. Obelis UK, as UK Responsible Person will gladly register your medical devices on the UK market!
- Medical Devices
- In-Vitro Diagnostics
- EU Representation
- Device Registration
- Person Responsible for Regulatory Compliance (PRRC)
Obelis can validate your Actor Registration on EUDAMED!Get in touch