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Guidance from the EU Commission/MDCG

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The Medical Device Coordination Group (MDCG) comprises participants from EU member states and the EU Commission. MDCG creates guidance for the Medical Device Regulation (MDR) and In-Vitro Diagnostic Regulation (IVDR).

The guidance is not legally binding but serves as a valuable resource for market participants. Its purpose is to ensure an efficient and harmonized understanding of the regulations.

MDCG Guidelines

The EU Commission has prepared fact sheets for various market participants.

Fact Sheets for Market Participants

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Units for medical devices

+ 47 22 89 77 00

medisinsk.utstyr@noma.no