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. In Luxembourg, devices are regulated by the the National Health Fund (Caisse nationale de santé – CNS).

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

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: On April 5, 2017, two new Regulations on medical devices were adopted, these entered into force on May 25, 2017 and replaced the existing Directives. The new rules will only apply after a transitional period, namely, 3 years after entry into force for the Regulation on medical devices (spring 2020) and 5 years after entry into force (spring 2022) for the Regulation on in vitro diagnostic medical devices.

Last updated on December 2019