It was confirmed by the European Commission on 30 October 2019 that the Medical Device Regulation (MDR) EUDAMED will be delayed for two years which will launch in May 2022.
The Commission is working on the implementation on the latest EUDAMED database which will improve the transparency and coordination of information regarding medical devices available on the EU market. It will contain a variety of modules such as actors, UDI & devices, notified bodies & certificates, vigilance, clinical investigations and performance studies and market surveillance. EUDAMED can only be ready after the entire system and its different modules have achieved full functionality and have been subjected to an independent audit. Therefore, EUDAMED’s launch will be done together for medical and in-vitro medical devices, at the original date foreseen for in-vitro medical devices i.e. May 2022. The date of application of MDR still remains May 2020.
Reasons that contributed to the delay are firstly, the MDR Eudamed modules are not ready yet and secondly, due to the change of medical devices from DG GROW and DG SANTE. The second reason caused an interruption which contributed a negative effect on the IT resources i.e. not all IT staff will remain in the project hence a major contribution to the delay.
This delay is seen as a blessing as companies now have more time to work on their project and even perfect it as well. Eudamed projects are costly in terms of resources and time. In addition, IT challenging as well. Companies will be able to save time and money as mistakes made will be lesser in the Eudamed projects. This will allow companies to prepare their systems as there is a need for 18 months from receipt of final specifications. In addition, the delay will not affect companies who have already started on their project as the data model for most of the part and data requirements will remain the same. If companies are done preparing their data groups, Basic UDI and UDI DI’s, heavily invested in training, and IT developments, this will not go to waste at all.
Source: EudaMed
contact us at info@arqon.com