Luxembourg medical device registration resources

Competent authority

Ministry of Health and Social Security — Directorate of Health (Direction de la santé); its Division de la pharmacie et des médicaments (DPM) acts as the national competent authority for me…

National legal framework for medical devices

Alongside MDR/IVDR, the marketing, importation, advertising and use of medical devices in Luxembourg are governed by: loi modifiée du 16 janvier 1990 relative aux dispositifs médicaux; Règl…

Old-Directive information-exchange provisions remain nationally regulated pending EUDAMED modules

Until the EUDAMED Vigilance and Clinical Investigation modules enter into force, several information exchange provisions of Directives 90/385/EEC, 93/42/EEC and 98/79/EC remain applicable a…

Device definition (MDR Art. 2(1))

A medical device is any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human b…

EU MDR classes I, Is, Im, Ir, IIa, IIb and III

Class I, Class Is, Class Im, Class Ir, Class IIa, Class IIb, Class III

National registration of Class I devices and IVDs

Before placing a Class I medical device or an IVD on the market, the manufacturer or authorised representative established in Luxembourg must register the device with the Direction de la sa…

EU CE under MDR/IVDR — single market validity

target: geo:lux · sourceApproval: EU CE under MDR/IVDR · edgeType: single market validity · marketAccessStrength: direct · regulatoryLayer: product marketing · sameDeviceRequired: Yes · loc…

National registration of manufacturers and authorised representatives

Any manufacturer established in Luxembourg placing devices on the market in its own name must register with the Direction de la santé (meddevices@ms.etat.lu); EU authorised representatives…

No distributor registration requirement

No registration is currently provided for distributors in Luxembourg — neither as economic operators nor for the devices they distribute — but this may change in the future. National langua…

Documents the CA may request per economic-operator type

During registration verification the Direction de la santé may request, depending on operator type (manufacturer MF / authorised representative AR / importer IM / system procedure pack prod…

Official form or portal surface

submissionSurface: EUDAMED (mandatory use from 28 May 2026) as the shared system, plus a national email channel: meddevices@ms.etat.lu for actor/device registration, custom made device regi…

Language requirement — active implantable medical devices

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

Language requirement — medical devices and IVDs

For medical devices and IVDs, the information to be provided to users and patients must be written in French, German or Luxembourgish. For devices intended exclusively for professional use,…

Manufacturer quality management system (Art. 10(9))

Manufacturers must establish, document, implement, maintain, keep up to date and continually improve a quality management system that ensures compliance with the Regulation in the most effe…

MDR electrical safety in place of the Low Voltage Directive

Electrical safety

MDR electromagnetic compatibility in place of the EMC Directive

EMC

Loi du 27 juin 2016 on making radio equipment available

Wireless / radio

No source-verified answer is published for this dimension yet.

Class I · Self-declaration (no notified body)

0 days

Certificate validity and renewal (Art. 56(2))

EU certificates issued by notified bodies are valid for the period they indicate, which may not exceed five years. On application by the manufacturer the validity of the certificate may be…

Changes to an approved type (Annex X, 5.1-5.3)

The applicant must inform the notified body that issued the EU type examination certificate of any planned change to the approved type or its intended purpose and conditions of use; changes…

EUDAMED use mandatory from 28 May 2026

From 28 May 2026 the use of EUDAMED becomes mandatory for many MDR/IVDR obligations, including actor registration, UDI/device registration, certificates and market surveillance; economic op…

Clinical investigation requires prior ministerial authorisation

In Luxembourg, every clinical investigation application and every substantial modification of a clinical investigation is additionally subject to prior authorisation by the Minister, based…

Clinical-investigation submission route and language rules

Until the EUDAMED Clinical Investigation module is operational, the applicant submits the clinical investigation application using the application form in Annex I of MDCG 2021 08, by email…

Conformity-assessment derogation application route (MDR Art. 59 / IVDR Art. 54)

For requests to place on the market / put into service a medical device or IVD on Luxembourg territory by derogation from the conformity assessment procedures (MDR Art. 59 / IVDR Art. 54),…

Custom-made device manufacturer registration and documentation

Manufacturers of custom made medical devices must transmit to the Direction de la santé (meddevices@ms.etat.lu): the duly completed registration form (formulaire enregistrement mdr ivdr.doc…

Post-market surveillance reporting (Arts. 83-86)

Manufacturers must implement a post market surveillance system (Art. 83) and a documented post market surveillance plan proportionate to the risk class and appropriate to the type of device…

National vigilance procedures continue until EUDAMED Vigilance module is operational

The EUDAMED Vigilance and Clinical Investigation modules are not yet operational; until their activation, national procedures continue to apply in Luxembourg. The CA page will be updated on…

Serious-incident reports (MDR Art. 87) to national mailbox with MIR form

Notifications under MDR Art. 87 must be sent to meddevices.vigilance@ms.etat.lu using the most recent version of the MIR (Manufacturer Incident Report) form available on the European Commis…

Market-surveillance authority and activities

Market surveillance of medical devices is the responsibility of the Direction de la santé, acting through the Division de la pharmacie et des médicaments (DPM), whose functions include insp…

Advertising of medical devices governed by national law

Luxembourg's competent authority page expressly lists the loi modifiée du 16 janvier 1990 relative aux dispositifs médicaux as the national legal basis governing medical device advertising,…

Eight-day hearing and motivated refusal before an adverse decision

Unless there is péril en la demeure, an authority that proposes of its own motion to revoke or modify a decision that created or recognised rights, or to take a decision without an initiati…

Three-month tribunal appeal and recours gracieux

Unless a special law or regulation sets a longer or shorter period, an action before the administrative tribunal is no longer admissible after three months from the day the decision was not…