MDCG releases new guidance on EUDAMED

February 28, 2021

EUDAMED is the new European database for medical devices and its first module became operational in December 2020. Rather than waiting until all six modules were ready, the EC released the “Actor Registration” module which allows manufacturers to register their company/devices and obtain a Single Registration Number (SRN). Because the first module is intended to work with the other five modules, the Medical Device Coordination Group (MDCG) released a new guidance document MDCG 2021-1 – Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional. The guidance provides helpful tables that cross reference different articles within the MDR and provide guidance on how to meet those requirements in the absence of a fully functional EUDAMED. It’s definitely worth adding to your growing collection of MDR reference documents. We maintain a complete list of relevant MDR and IVDR guidance documents here.

More news