The Medical Device Coordination Group (#MDGC) has published a new guidance document, “MDCG 2021-5 – Guidance on Standardisation For Medical Devices”.   The document concerns a variety of issues regarding standardisation of med devices, especially the legislative framework of EU standards, require/voluntary use of standards, “state of the art” and assessment of current harmonise standards.

Key Takeaways

(1)    Discussion of the relationship between harmonized EU legislation and standards (Annex Z)

(2)    Publication in the OJEU of references to harmonised EU standards

(3)    Governance structures for standards

(4)    International aspects of standardisation

(5)    “Therefore, also in the medical devices field in the EU, choosing to use a standard or not belongs to the manufacturer,”

(6)    “specific assessment of the draft standards under development is carried out by the “Harmonised Standards (HAS) consultants”,”

(7)    “the mere compliance with the most recent version of a standard which reference is not listed in the OJEU does not automatically imply compliance with the requirements of the applicable EU legislation”

🔍 See the pdf here : https://bit.ly/3enqFmH