- info@omcmedical.co.uk
Get In Touch:
Get In Touch:
- info@omcmedical.co.uk
Luxembourg
Medical Device Registration in Luxembourg
Ministry of Health
Ministry of Health
Regulatory Authority
Ministere de la Sante
Medical Device Regulation
EU MDR 2017/745
Official Language
French, German & Luxembourgish
Classification
Class I, IIa, IIb and III
Registration Process
- Determine the device classification
- Appoint Authorized Representative and Notified Body
- Class I device can be Self-Certified. QMS necessary but Notified Body intervention is not required.
- For other classes, prepare a CE Technical File
- Obtain and register UDI in EUDAMED.
- Technical File should be audited by Notified Body.
- Once approved, prepare a Declaration of Conformity.
- The device can now be marketed in Luxembourg
Documents Required
- CE Certificate
- Declaration of Conformity
- Technical File
- QMS Certificate
- Risk Management Plan
- IFUs, Label or User Manual
- Clinical Studies Report
- Postmarket Surveillance Plan
Post-market Requirements
- Serious public health threats – 2 day
- Death or serious health deterioration – 10 days
- Other serious incidents – 15 days
Applicable QMS
ISO 13485
Registration Timeline
Class I – 4-6 weeks
Others – Based on the timeline by Notified Body
Authorized Representative
Yes
License Validity
5 years
Want to know more about this registration process?
Quick Contact
If you have any questions or need help, feel free to contact with our team.
Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
Quick Contact
If you have any questions or need help, feel free to contact with our team.
Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
Quick contact
- info@omcmedical.co.uk
-
0044 7719761764
0044 2080667260 - Planet House, North Heath Lane, Horsham, West Sussex RH12 5QE
Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
Our Branches
- Switzerland
- Europe (Northern Ireland)
- Asia
- Canada
- Brazil
- Middle East
- China
- Turkey (Partner Office)
To launch a medical device in a country, medical devices must comply with the local country’s regulatory requirements. Let us be your trusted partner in bringing your medical devices to the Global market. Contact us today to learn more about how we can assist you in every step of the way.
Our Branches
- Europe
- Asia
- Africa
- Oceania
- South America
- North America
- Planet House, North Heath Lane, Horsham, West Sussex RH12 5QE
- Planet House, North Heath Lane, Horsham, West Sussex RH12 5QE