Medical devices and CE marking

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Fiche de renseignement demande dérogation de procédures conformité

The regulatory framework for medical devices in Europe and Luxembourg is determined by several regulatory texts, at both national and European levels.

At the European level, 2 regulations on medical devices apply:

Pending the roll-out of the various modules of the EUDAMED medical device database, certain provisions of directives 90/385/EEC, 93/42/EEC and 98/79/EC on the exchange of information remain applicable and are regulated at the national level.

Detailed information is available in the guidance documents adopted by the MDCG (Medical Device Coordination Group).

Consequently, certain national provisions that apply to you – such as the registration of medical devices, the registration of economic operators and the authorisation of a clinical investigation – remain applicable.

In this regard, marketing, importing, advertising and using medical devices are governed by law at the national level.

Who is concerned

Manufacturers of medical devices that bear the CE marking.

Prerequisites

Conformity of medical devices

Any medical device with the CE marking, which indicates that the device underwent a conformity assessment, may be placed on the market and put into service. Before placing the device on the market, you must establish the declaration of conformity, in which you must state that the medical device adheres to the provisions of the standards that apply to it.

Regulation (EU) 2023/607 established extended transitional periods for the conformity of devices that have not been assessed according to the MDR or IVDR. In addition, Regulation (EU) 2024/1860 amended the transitional periods for in vitro diagnostic medical devices.

For more information, you may also view the following MDCG documents:

Language requirements

For active implantable medical devices, the instructions that you are required to provide to users and patients must be written in either French or German.

For medical devices and in vitro diagnostic medical devices, the instructions that you are required to provide to users and patients must be written in French, German or Luxembourgish.

For devices intended solely for professional use, the instructions may also be written in English.

To find out the language requirements for medical device manufacturers, please refer to the European Commission's dedicated website.

How to proceed

Registration of manufacturers and economic operators

If you are a manufacturer and are placing devices on the market under your own name, you must register with the Health Directorate (Direction de la santé) by email: meddevices@ms.etat.lu.

If a manufacturer does not have their registered office in an EU Member State, they must appoint a single representative in the European Union (EU). All European representatives established in Luxembourg must register with the Health Directorate by email: meddevices@ms.etat.lu.

If you are an economic operator (representative, importer, system and procedure pack producer) established in Luxembourg, you can register through the EUDAMED Actor Registration Module. Registration applications must be approved by the competent authority.

You are encouraged to register promptly, given the time frames stipulated in Regulation 2024/1860.

Distributors in Luxembourg are not currently required to register, but this could change in the future.

Registering a medical device or in vitro diagnostic medical device

Before marketing a medical device or an in vitro diagnostic medical device, you as the manufacturer or your representative must register the class I device or the in vitro diagnostic medical device with the Health Directorate, if you or your representative is established in Luxembourg.

To that end, you must send the following documents to meddevices@ms.etat.lu:

  • a recent extract from the Trade and Companies Register (RCS) (less than 3 months old);
  • the declaration of conformity;
  • where applicable, the valid certificate(s) of conformity;
  • if applicable, the quality management system (QMS) certificate;
  • the instructions for use;
  • a copy of the labelling;
  • in some cases, the medical device's technical documentation may be requested.

If you have any additional questions, you may send an email to meddevices@ms.etat.lu.

Registering a higher-class medical device

You may register higher-class medical devices directly in EUDAMED once the registration of the relevant economic operators (manufacturer and/or representative, where applicable) has been approved.

The Health Directorate reserves the right to ask you for any relevant documents that prove the conformity of the devices in question.

In Luxembourg, if you are a medical device distributor, you are not required to register the distributed devices with the Health Directorate. Nevertheless, you must meet the language requirements at national level (see the 'Language requirements' section above).

Application for exemption

If you are applying to place on the market or put into service a medical device or in vitro diagnostic medical device in Luxembourg, by way of an exemption from the conformity assessment procedures, you are required to submit the completed application form, along with all the related documents, by email to meddevices@ms.etat.lu. Only the complete application file will be processed.

Online services and forms

Downloadable forms

Note: view tips for using PDF forms.

Fiche de renseignement demande dérogation de procédures conformité

Information sheet application for derogation from conformity procedures
Pdf

Other language(s)

Who to contact

ILNAS - Product Contact Point (PCP)

Address:
1, avenue du Swing L-4367 Belvaux Luxembourg
Phone:
(+352) 24 77 43 20
Email address:
pcpluxembourg@ilnas.etat.lu

Ministry of Health and Social Security Division of Pharmacy and Medicines

Address:
2a, rue Thomas Edison L-1445 Strassen Luxembourg
Phone:
(+352) 247 85 592
Email address:
pharmacovigilance@ms.etat.lu
Website:
http://sante.public.lu/fr/politique-sante/ministere-sante/index.html

Related procedures and links

Liens

Legal references

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