Medical Device Registration and Approval in Luxembourg

General country-specific regulatory information is provided on this page for medical device registration and approval in Luxembourg. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, including Luxemburg, to expedite the preparation of your medical device or IVD registration application.

Medical Device Regulations and Classification in Luxembourg

REGULATORY AUTHORITY: Devices are regulated by the EU list of Competent Authorities.

CLASSIFICATION SYSTEM: Medical devices are classified according to risk into Classes I, IIa, IIb, III, and IV.

TIMEFRAME: The registration process takes about 4-6 weeks after submission for Class I devices. For the other classes, it depends on the contract with the notified body and the type of device.

LICENSE VALIDITY: Licenses issued in the EU are valid for five years.

AUTHORIZED REPRESENTATIVE: An authorized representative anywhere in the European Union is required.

ADDITIONAL INFORMATION: The Medical Device Directive is due to be changed in 2015.

Last updated on March 17 2015.