Medical Device Regulatory Requirements in Germany

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

Regulatory Authority The Federal Institute for Drugs and Medical Devices
Regulatory Authority Website Link Click Here
Device Classification I, IIa, IIb and III
Medical Device Regulations Laws and Regulations | Click Here
IVD Classification A,B,C,D
In Vitro Diagnostics Regulations (EU) 2017/746 | Click Here
Registration Process Registration of Medical Device (Search Registration keyword) | 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 Labels must be in German Language
Database DMIDS | Click Here
Additional Information

According to German law, the state authorities are responsible for market access issues of medical devices
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 We are not responsible for errors, omissions, or outdated content.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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