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.
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