The European Commission’s (EC) Medical Device Coordination Group (MDCG) has recently issued guidance on harmonised administrative practices and alternative technical solutions to be used until the European database on medical devices (EUDAMED) is fully functional.
The EC has already acknowledged that in order to be classed as fully functional, all six modules of EUDAMED need to be fully operational, both individually and in conjunction with one another. However, whilst the date of application of the European Union Medical Device Regulations (EU MDR) is 26 May 2021, EUDAMED is not set to be fully launched until May 2022. As such, many of the requirements of the MDR that relate to EUDAMED can’t be conducted until all modules of the database are fully operational.
The recently released guidance document details alternative solutions to fulfil these MDR requirements without EUDAMED. In particular, it is noted that the necessary exchanges of information may be difficult or even impossible. One example alternative solution is the use of the CircaBC directory. The MDCG has also stated that the EC will make EUDAMED modules available to relevant stakeholders as and when they are completed.
The EC will publish a notice declaring when EUDAMED is fully functional. EUDAMED related requirements of the MDR shall apply from 6 months after this notice is released. Furthermore, all information generated and collected after the date of application of the MDR needs to be reported into EUDAMED as soon as it becomes operational.
To view the alternative provisions in full, click here.