Medical devices

Mandatory use of EUDAMED from 28 May 2026

IMPORTANT UPDATE

As of 28 May 2026, the use of the European Database on Medical Devices (EUDAMED) becomes mandatory for many MDR/IVDR obligations, including Actor Registration, UDI/Device Registration, Certificates and Market Surveillance. Economic operators are strongly encouraged to complete their EUDAMED registration and upload their data as early as possible.

The Vigilance and Clinical Investigation modules are not yet operational. Until their activation, national procedures continue to apply in Luxembourg. This page will be updated as soon as the European Commission announces the entry into force of these modules.

EU & National Legal Framework

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, certifying successful conformity assessment, may be placed on the market and put into service. Before placing a medical device on the market, the manufacturer draws up a declaration of conformity, in which they certify that the medical device in question meets the applicable requirements.

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 applicable to in vitro medical devices. For further information, please refer to the following MDCG documents:

Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices
Q&A on practical aspects related to the implementation of the extended transitional period provided for in the IVDR, as amended by Regulation (EU) 2024/1860 of 13 June 2024 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, the obligation to inform in case of interruption or discontinuation of supply, and transitional provisions for certain in vitro diagnostic medical devices

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 provided 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:

Overview of language requirements for manufacturers of medical devices - European Commission

Registration of economic operators

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

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

Given the mandatory use of EUDAMED, Luxembourg recognizes the registration in the system as fulfilment of national requirements for manufacturers and authorised representatives.

Other economic operators such as importers and systems/procedure pack suppliers, established in Luxembourg, should also register themselves using the EUDAMED Actor Registration Module. All registration requests must be approved by the competent authority.

In view of the timeframes specified in Regulation (EU) 2024/1860 and in Decision 2025/2371, the above-mentioned economic operators are encouraged to register as early as possible.

During the verification process, the Luxembourg Health Directorate may request additional documents, depending on the type of the economic operator:

	Economic operator
Document	MF	AR	IM	PR
Declaration of Conformity	☑	☑ (from MF)	☑	☑ (if applicable)
CE Certificate(s)	☑	☑	☑	☑ (if applicable)
QMS certificate (if applicable)	☑	☑	—	—
Device labelling	☑	☑	☑	☑ (if applicable)
Instructions for Use (IFU)	☑ (if applicable)	☑ (if applicable)	☑ (if applicable)	☑ (if applicable)
PRRC qualifications (Art. 15 of the MDR/IVDR)	☑	☑	—	—
Mandate / contract MF ↔ AR	—	☑	—	—
Designation of the device(s) to be imported / included	—	—	☑	—
Confirmation whether MF is registered in EUDAMED	—	☑	☑	—
Confirmation whether AR is registered in EUDAMED	—	—	☑	—
Declaration according to MDR Article 22(1)	—	—	—	☑

Vigilance

Vigilance reports – including MIRs (Manufacturer’s Incident Reports), FSCAs (Field Safety Corrective Actions), PSURs (Periodic Safety Update Reports), periodic summary reports (PSRs), and trend reports (TRs) – must be sent to meddevices.vigilance@ms.etat.lu, using the most recent version of the form on the European Commission website.

Manufacturers are encouraged to use the European Medical Device Nomenclature (EMDN).

MIR and FSCA form submissions should be sent in PDF or XML format.

For FSNs (Field Safety Notices), we suggest that you submit at least the French and German versions – in addition to the English version – to reflect the Luxembourg medical sector's linguistic landscape. FSCA notifications should also be accompanied by:

the list of Luxembourg users/customers concerned by FSCA;
an overview of the number of products concerned that are available on the Luxembourg market;
confirmation that the FSN was sent to Luxembourg users/customers.

We also recommend that you read the MDCG guidance documents, and especially:

Reporting of serious incidents by healthcare professionals

What is an incident?

Any malfunction or deterioration in the characteristics or performance of a device, including use-error due to ergonomic features, as well as any inadequacy in the information provided by the manufacturer,

and any adverse side effects (in the case of medical devices).
and any harm arising as a consequence of a medical decision, and of action taken or not taken on the basis of information or the result(s) provided by the device (in the case of in vitro diagnostic medical devices).

What is a serious incident?

Any incident that directly or indirectly led, might have led or might lead to:

the death of a patient, a user or any other person;
a temporary or permanent serious deterioration in the health of a patient, user or any other person;
a serious threat to public health.

Manufacturers of custom‑made medical devices

Manufacturers of custom‑made medical devices must submit following documents to the Health Directorate (meddevices@ms.etat.lu) :

The duly completed registration form (Word, 261 Kb)
Recent copy of the extract from the RCS (Registre de Commerce et des Société)
Model declaration set out in Annex XIII of the MDR,
Valid certificates of conformity, if applicable,
QMS certificate, if applicable,
Labelling and IFU (instructions for use), if applicable,
Documents demonstrating the qualifications of the Person Responsible for Regulatory Compliance (PRRC) (Art. 15 of the MDR).

They are also required to submit a list of custom‑made devices placed into service in Luxembourg (meddevices@ms.etat.lu).

Distributors

Currently, no registration is 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, any manufacturer or authorised representative established in Luxembourg must register the class I devices or the in vitro diagnostic medical devices with the Health Directorate. Given the mandatory use of EUDAMED, Luxembourg considers the registration in the system as fulfilment of national requirements. Nevertheless, the Health Directorate reserves the right to request any documents proving the conformity of the devices concerned that not available in EUDAMED:

Declaration of Conformity
QMS certificate, if applicable
IFU (Instruction for Use)
Copy of the labelling.
In certain cases, Technical Documentation may also be requested.

Distribution

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

Last update 20.07.2026