Next Steps for EUDAMED implementation within MDR
By Jean Boudaud, director and head of medical devices/IVD, Australia, at PharmaLex
When the Medical Devices Regulation (MDR) came into force in May 2017, it was missing a key operational component to allow full compliance of the new regulation: the European Database for Medical Devices (EUDAMED).
EUDAMED supports operational implementation of both the MDR (which replaces the Medical Devices Directive (MDD) and Active Implantable Medical Devices Directive (AIMDD) and the In Vitro Diagnostics Regulation (IVDR), with the goal of improving transparency and availability of information (including with the public) regarding medical devices available on the EU market. Its operation is critical to more current ways of regulating medical devices, through adoption of a complete lifecycle approach to the management of device safety and reinforcement of postmarket surveillance systems.
As it stands today, of the six interconnected modules planned within EUDAMED, only three are available. For the past couple years (and until EUDAMED becomes fully operational), companies have therefore been unable to comply with all aspects of the new regulations. Currently available modules are:
- Actor registration — available since December 2020, enabling economic operators to obtain an actor identifier/single registration number
- UDI/Devices registration – available since October 2021, which allows easier traceability of medical devices. This capability is entirely new to Europe, although UDIs have been in place in other regions for some time. Manufacturers will have to implement this UDI system for their products based on class and on use scenarios
- Notified Bodies and Certificates – also available since October 2021, through which notified bodies register any information regarding certificates issued, suspended, reinstated, withdrawn, or refused and other restrictions imposed on these certificates.
The three modules yet to be completed are:
- Clinical Investigations and performance studies
- Vigilance and post-market surveillance
- Market Surveillance
Just recently, the EU commission released its target timelines for implementation. Although past experience would suggest current timelines are overly optimistic, it is expected that the database will be fully released by Q4 2022. The database will then be subject to an independent audit, the results of which will be presented to the Medical Devices Coordination Group (MDCG). From there, progressive enforcement of the use of all modules is expected until Q2 2025. Mandated application of the database will be communicated by the commission through a notice in the Official Journal.
The use of EUDAMED remains voluntary until full implementation. However, manufacturers and economic operators are encouraged to start using all modules available to them and ensure all changes to their quality systems are implemented immediately (e.g. postmarket and UDI systems).
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