Medical Device Regulatory Requirements in Denmark

Governed by the European Union Medical Device and IVD Regulations (EU 2017/745, 2017/746)

Regulatory Authority Danish Medical Agency
Regulatory Authority Website Link Click Here
Device Classification I, IIa, IIb and III
Medical Device Regulations Legislation and guidance on medical devices | Click Here
IVD Classification A,B,C,D
In Vitro Diagnostics Regulations (EU) 2017/746 | Click Here
Registration Process Registration and marketing | Click Here
Registration Timeline For Class I, it is 1 to 2 months and for other classes, it depends on the notified body and type of product
Requirement of Authorized Representative Yes
Language Requirement The labelling and instructions for use of medical devices must be in Danish.
Database RZPRO | Click Here
Additional Information

Regulatory advice for medical device companies
Disclaimer: This website sources information from regulatory authorities and aims for accuracy, but regulations may change without notice. Users are advised to verify details with relevant authorities before making compliance decisions. We are not responsible for errors, omissions, or outdated content.

The above information is last updated on 07/Oct/2025

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