Medical devices

Medical devices in Luxembourg

At European level, there are currently two regulations that apply to medical devices:

  • Regulation (EU) 2017/745 on medical devices (MDR), since 26 May 2021;
  • Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), since 26 May 2022.

Pending the entry into force of several EUDAMED (European Database for Medical Devices) modules, certain provisions of Directives 90/385/EEC, 93/42/EEC and 98/79/EC on the sharing of information still apply and are regulated at national level. Full details can be found in the guidance documents adopted by the Medical Devices Coordination Group, hereafter referred to as the MDCG.

As such, certain national provisions still apply – for instance, provisions governing the registration of devices, the registration of economic operators, and authorisations to conduct clinical investigations.

In that regard, the marketing, importation, advertising and use of medical devices are governed, at national level, by:

the Law of 16 January 1990 (as amended) on medical devices;

  • the Grand Ducal Regulation of 5 February 1993 (as amended) on active implantable medical devices;
  • the Grand Ducal Regulation of 11 August 1996 (as amended) on medical devices;
  • the Grand Ducal Regulation of 24 July 2001 (as amended) on in vitro diagnostic medical devices.

Conformity of medical devices

Any medical device bearing the CE marking – which indicates that it has passed a conformity assessment – may be placed on the market and put into service. Before placing a medical device on the market, the manufacturer must file a declaration of conformity, in which it declares that the medical device in question meets the applicable standards.

Regulation (EU) 2023/607 has introduced extended transitional periods for devices whose conformity has not been assessed in accordance with the MDR or the IVDR. Furthermore, Regulation (EU) 2024/1860 has amended the transitional periods that apply to in vitro medical devices. For further information, please refer to the following MDCG documents:

Language requirements

For active implantable medical devices, the information to be provided to users and patients must be written in either French or German.

For medical devices and in vitro diagnostic medical devices, the information to be provided to users and patients must be written in French, German or Luxembourgish.

For devices intended for professional use only, the information may also be written in English.

For further details about the language requirements for medical devices in Luxembourg, you may also refer to the following page published by the European Commission:

Registration of economic operators

Any manufacturer established in Luxembourg that places medical devices on the market in its own name must register with the Luxembourg Health Directorate (meddevices@ms.etat.lu).

If a manufacturer's registered office is not in a Member State, it must designate a sole authorised representative in the European Union (EU). All European authorised representatives established in Luxembourg must register with the Luxembourg Health Directorate (meddevices@ms.etat.lu).

Economic operators (manufacturers, authorised representatives, importers, and systems/procedure pack suppliers) established in Luxembourg may register using the EUDAMED Actor Registration Module, depending on the applicable Regulations. All registration requests must be approved by the competent authority.

Given the time frames specified in Regulation 2024/1860, the above-mentioned economic operators are encouraged to register as quickly as possible.

Currently, registration is not required for distributors in Luxembourg. However, this may change in the future.

Registration of devices

Before placing a medical device or an in vitro diagnostic medical device on the market, the manufacturer, or its authorised representative, must register the Class I device or the in vitro diagnostic device with the Health Directorate, if it is established in Luxembourg. To register the device, the applicant must send the following document to meddevices@ms.etat.lu:

  • An extract from the Luxembourg Trade and Companies Register (Registre de commerce et des sociétés - RCS), issued no more than 3 months prior to the application
  • Declaration of conformity
  • Valid certificate(s) of conformity, where applicable
  • Quality Management System (QMS) certificate, if applicable
  • Instructions for use
  • Copy of labelling
  • In some cases, the device's technical documentation may also be required.

If you have any further questions, please contact us by email at meddevices@ms.etat.lu.

Medical devices belonging to higher classes may be registered directly in EUDAMED, provided that the registration of the economic operators concerned (manufacturer and/or authorised representative) has been approved. The Luxembourg Health Directorate reserves the right to request any relevant documents establishing the conformity of the devices concerned.

In Luxembourg, medical device distributors are not required to register the medical devices that they distribute with the Luxembourg Health Directorate. However, the national-level language requirements must be fulfilled (see 'Language requirement' above).

Applying for an exemption

Regarding applications to place devices on the market/put devices into service: By way of derogation from the conformity assessment procedures applicable to medical devices/in vitro diagnostic medical devices in Luxembourg, pursuant to Article 59 of the MDR and Article 54 of the IVDR, the applicant must submit the completed form, along with all relevant documents, to: meddevices@ms.etat.lu.

Only complete files will be processed.

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