EC: Updated MDR/IVDR Guidance on Standardisation for Medical Devices

The Medical Device Coordination Group (MDCG) has updated its guidance on standardisation for medical devices, including topics such as the European Pharmacopoeia and common specifications.

The original document, published in 2021, covered the general framework for harmonised European standards and their support for legislation on medical devices. The recent revisions include a new subsection on the European Pharmacopoeia, explaining its relationship to the MDR/IVDR, and outlining the meaning of references to "common specifications".

Additionally, MDCG added a point on the Court of Justice of the European Union’s rulings on standardisation, describing six rulings that affect standardisation of medical devices. The guidance also features revisions to existing sections, including references to ISO standards in MDR and IVDR, and clarifications on the scope and applicability of IVDR requirements related to a standard on the quality and competence of medical laboratories.

Source:

EC: MDCG Guidance