Medical Device Regulatory Requirements in Luxembourg
| Regulatory Authority |
Ministry of Health |
| Regulatory Authority Website Link |
Click Here
|
| Device Classification |
I, IIa, IIb and III |
| Medical Device Regulations |
Medical Devices Regulation
| Click Here
|
| IVD Classification |
A,B,C,D |
| In Vitro Diagnostics Regulations |
(EU) 2017/746
| Click Here
|
| Registration Process |
Medical Devices Registration
| 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 French or German or Luxembourgish Language
Labels for AIMD should be in French or German |
| Adverse Event Reporting Form |
Download |
| Additional Information |
Any medical device bearing the CE marking, indicating that it has been subject to a conformity assessment, can be made available on the market and put into service. |
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 We are not responsible for errors, omissions, or outdated content.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