Medical Device Regulatory Requirements in Germany
| 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
|
| Adverse Event Reporting Form |
Download |
| 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 We are not responsible for errors, omissions, or outdated content.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 09/Apr/2025