Explore the IVD requirements currently available for Luxembourg, organized by topic and linked to official sources.
Source-linked rules for common changes to a registered IVD. Read the scope and conditions with each rule; unverified details are listed separately.
A change to the registered brand name and a change to logo artwork can follow different rules. The legal manufacturer, device design and intended purpose remain the same.
A source-verified answer for this specific scenario is not yet published.
The same legal manufacturer changes its name, potentially alongside the device brand. A transfer to another legal entity is a separate question; permission to combine filings needs its own evidence.
A source-verified answer for this specific scenario is not yet published.
An office address change for the same legal entity, potentially alongside name and brand changes. This does not cover moving a factory or manufacturing site, and a combined filing cannot be assumed.
A source-verified answer for this specific scenario is not yet published.
Check which identifier actually changes. A commercial catalogue, REF or order code is not automatically a device model, registered identifier, GTIN or UDI-DI. Rules for one identifier do not establish the route for another.
A source-verified answer for this specific scenario is not yet published.
A real change of legal manufacturer, registration holder or owner. This differs from renaming the same entity; a change of local representative or importer alone does not establish a registration transfer route. Where other changes occur with the transfer, the exact combination and sequence need separate evidence.
A source-verified answer for this specific scenario is not yet published.
Changes to brand, manufacturer name, office address and reference codes may occur together, including with a real transfer to another legal manufacturer, registration holder or owner. Assess transfer with each single change, and transfer with brand plus reference, manufacturer name plus reference, or office address plus reference changes: seven transfer combinations in total. Evidence must establish the exact combination and the order of filings and approvals. These combinations and their sequence are not all verified by the rules below; a rule for one change does not prove that a single application, fee or review period covers the combination.
A source-verified answer for this specific scenario is not yet published.
What local class follows from which rules and decisive product facts?
Luxembourg maintains no national classification scheme: the directly applicable EU MDR Art. 51 and Annex VIII classes (I, Is, Im, Ir, IIa, IIb, III) — and IVDR Art. 47 and Annex VIII for IVDs — govern through the CE-marking regime. National overlays administered by the Direction de la santé: manufacturers and authorised representatives established in Luxembourg must register with the Direction de la santé (registration in EUDAMED satisfies the national registration requirement), and class I devices and IVDs must be registered with the Direction de la santé before being placed on the market.
Which evidence, local deltas, formats, and signatures are required?
During registration verification the Direction de la santé may request, depending on operator type (manufacturer MF / authorised representative AR / importer IM / system-procedure-pack producer PR): declaration of conformity; conformity certificates; QMS certificate; labelling; IFU; PRRC qualifications (Art. 15 MDR/IVDR); mandate/contract manufacturer-AR; designation of devices to be imported; confirmation of manufacturer's and AR's EUDAMED registration; declaration per MDR Art. 22(1).
MF = fabricant (manufacturer), AR = mandataire, IM = importateur, PR = fournisseur de systèmes et nécessaires.
Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?
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 established in Luxembourg must likewise register. Luxembourg recognises EUDAMED registration as fulfilling these national requirements. Importers and system/procedure-pack suppliers established in Luxembourg register via the EUDAMED Actor Registration Module; every registration request must be validated by the competent authority.
Operators are encouraged to register early given Regulation (EU) 2024/1860 and Decision 2025/2371 timeframes.
Which establishment licences, importer permissions, and distribution controls apply?
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 language requirements must still be met for distributed devices.
Sections 'Distributeurs' and 'Distribution'.
Which label and IFU elements, languages, symbols, and translation controls apply?
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, the information may also be provided in English.
National language delta beyond MDR Art. 10(11); also applies to devices distributed in Luxembourg (see 'Distribution' section).
Which current law, regulation, guidance, and transition provisions apply?
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; Règlement grand-ducal modifié du 5 février 1993 (active implantable medical devices); Règlement grand-ducal modifié du 11 août 1996 (medical devices); Règlement grand-ducal modifié du 24 juillet 2001 (in vitro diagnostic medical devices).
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 and are regulated at national level — e.g. national provisions on device registration, economic-operator registration and clinical-investigation authorisation.
Transitional national-continuity rule pending full EUDAMED roll-out (Regulation (EU) 2024/1860 context).
Which current form, portal, account, and submission package must be used?
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 registration and MDR Art. 59 / IVDR Art. 54 derogation applications; recherchebiomedicale@ms.etat.lu and meddevices@ms.etat.lu for clinical-investigation applications (MDCG 2021-08 Annex I form); meddevices.vigilance@ms.etat.lu for vigilance (MIR form)
No national online portal; email-based procedures with Word/PDF forms continue until the respective EUDAMED modules are operational.
Baseline caveat 'routine surface incomplete' now completed: the current CA pages document registration, custom-made, derogation and clinical-investigation surfaces.
Which recall, FSCA, notice, and authority-coordination duties apply?
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 inspecting and regularly controlling the informal market, including e-commerce, to prevent illegal trade in health products; from 28 May 2026 EUDAMED market-surveillance use is mandatory.
DPM market-surveillance activities also include inspections and handling of establishment-authorisation requests (see DPM 'Surveillance du marché' page).
Which registration, notification, listing, reliance, or conformity route applies?
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 santé; registration in EUDAMED (mandatory use from 28 May 2026) is accepted as fulfilling this national requirement. The CA reserves the right to request supporting documents not available in EUDAMED (declaration of conformity, QMS certificate, IFU, labelling copy, in certain cases technical documentation).
Contact for registration: meddevices@ms.etat.lu.
Which foreign decisions or evidence can be reused, with what effect and conditions?
Existing records include acceptance, restrictions and evidence reuse. The applicable product scope and conditions are preserved below; a reference does not by itself confer market access.
No linked record is currently maintained. This does not establish that a pathway is unavailable.
Prior approval / evidence record
FDA 510(k)/PMA
No
No substitute for EU MDR conformity assessment; useful as predicate documentation in the technical file
Maintained reference · planning ranges remain estimates · reviewed 2026-08-29
Regulatory reference
For ordinary market placement under MDR/IVDR, a Chinese approval does not replace conformity assessment under MDR Article 52 or IVDR Article 48. The applicable EU class and procedure must be established independently; lower-risk devices may self-declare, while other devices require notified-body assessment. This is a finding about the ordinary conformity route, not a ban on Chinese devices or their technical evidence.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
luxembourg
All NMPA classes (I filing, II, III) -> all EU MDR/IVDR classes
No Reliance Route
none
Product Marketing
null
null
Independent review of current EUR-Lex consolidations supports this bounded ordinary-route conclusion. It does not establish the absence of every special route.
Prior approval / evidence record
geo:lux
EU CE under MDR/IVDR
Single Market Validity
direct
Product Marketing
Yes
No
No
Confirmed on the Luxembourg CA website; national conditions (registration, language, vigilance) still apply.
Is an emergency, compassionate, custom, humanitarian, or other exceptional path available?
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), the applicant must submit the completed 'Fiche de renseignement – demande de dérogation de procédures de conformité' form together with all relevant documents to meddevices@ms.etat.lu; only complete dossiers are processed.
Section verified in the page version consulted on 2026-08-25 (last modified 05.01.2026); it was not visible in the post-28 May 2026 EUDAMED-update version of the same page — confirm current form availability with the DPM.
Which UDI, device listing, database, and traceability duties apply?
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 operators are strongly encouraged to complete their EUDAMED registration and transfer their data as early as possible.
Effective from 2026-05-28
Luxembourg accepts EUDAMED registration as fulfilling national registration requirements.
What is reportable, by whom, where, in what format, and by what deadline?
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 once the European Commission announces the entry into application of these modules.
National vigilance channel: meddevices.vigilance@ms.etat.lu (see related fact on MIR reporting).
No maintained record.
These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.
Luxembourg
luxembourg
LU
🇱🇺
Direction de la santé, Ministry of Health and Social Security
Directorate of Health
europe
3
4-class (I, IIa, IIb, III) — EU MDR
class-i
Class I
low
Self-declaration (no notified body)
0
0
days
official-verified
EUR-Lex Regulation (EU) 2017/745 (MDR)
https://eur-lex.europa.eu/eli/reg/2017/745/oj
2026-08-25
6
9
months
No
No
Yes
FDA 510(k)/PMA
No
No substitute for EU MDR conformity assessment; useful as predicate documentation in the technical file
Yes
EU Authorized Representative
No
ISO 13485 accepted as QMS evidence
5 years (CE certificate)
2026-08-29
partially-verified
Commission Implementing Regulation (EU) 2026/977, Art. 2 — maximum notified-body conformity assessment timelines (30 + 120/90 parallel + 20 days)
https://eur-lex.europa.eu/eli/reg_impl/2026/977/oj
2027-02-25
2026-08-29
EUR-Lex Regulation (EU) 2017/745 (MDR)
https://eur-lex.europa.eu/eli/reg/2017/745/oj
2026-08-25
EUR-Lex MDR consolidated text — Annex IX §5.1 (expert-panel clinical evaluation consultation: 21/60 days) and §5.2(d) (ancillary medicinal-substance opinion: 210 days)
https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:02017R0745-20250110
2026-08-29
2026-08-29
default
planning-template
Maintained planning steps and estimates, not verified regulator deadlines.
1
Pre-Submission Preparation
Gather technical documentation, quality management system (QMS) records, and clinical data required by Directorate of Health. Appoint a EU Authorized Representative.
1-3 months
📋
2
Application Submission
Submit complete registration dossier to Directorate of Health including device description, risk analysis, and testing reports.
1-2 weeks
📤
3
Administrative Review
Directorate of Health reviews application for completeness. May request additional documents or clarifications.
2-4 weeks
🔍
4
Technical Evaluation
In-depth technical assessment of device safety and performance. Directorate of Health may issue questions.
0 days
⚙️
5
Registration Approval
Upon successful review, Directorate of Health issues Luxembourg market authorization certificate.
1-2 weeks
✅
These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.
No maintained record.
These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.
luxembourg
Luxembourg
high
lvd-medical-exclusion-mdr-electrical-safety
MDR electrical safety in place of the Low Voltage Directive
Medical Electrical Safety
Included In Medical Registration
Finished Device
Annex II of Directive 2014/35/EU places electrical equipment for radiology and medical purposes outside the Low Voltage Directive, so there is no separate national electrical-safety certificate for a medical device. Electrical safety is assessed inside the MDR conformity assessment against MDR Annex I, with the harmonised IEC/EN 60601 series carrying the presumption of conformity.
candidate
emc-directive-disapplied-by-mdr
MDR electromagnetic compatibility in place of the EMC Directive
emc
Included In Medical Registration
Finished Device
Article 2(3) of Directive 2014/30/EU switches the EMC Directive off where other Union legislation lays the same essential requirements down more specifically, which MDR Annex I sections 18.5 and 18.6 do for medical devices. EMC is therefore dossier evidence inside the CE route and not a separate national EMC conformity step.
candidate
loi-2016-radio-equipment-free-movement
Loi du 27 juin 2016 on making radio equipment available
Radio Spectrum
Mandatory If Feature
Radio Equipment
Article 7 of the loi modifiée of 27 June 2016 has the ILNAS market surveillance department authorise the putting into service and use of radio equipment that complies with the law when properly installed, maintained and used for its purpose, and article 9(1) provides that making compliant radio equipment available on the market may not be obstructed on grounds covered by the law. That free-movement clause is an express negative: no Luxembourg type approval appears anywhere in the text. ILR supplies the regulated radio interfaces that ILNAS notifies, and spectrum authorisations run under the loi modifiée of 30 May 2005. The consolidated text read is the version as at 27 December 2019; the loi of 3 March 2026 transposing Directive (EU) 2024/2839 has since amended it, so article numbering may have moved.
candidate
rgd-2013-rohs-substance-restriction
Règlement grand-ducal du 30 juillet 2013 substance restriction (RoHS)
Environmental And Batteries
Evidence Only No Separate Certificate
Electrical Electronic Medical Device
Article 3(1) and (2) of the règlement grand-ducal modifié of 30 July 2013 provide that EEE placed on the market, including cables and spare parts for repair, reuse, functional updating or capacity upgrading, contain none of the Annex II substances above the maximum concentration by weight in homogeneous materials. The coordinated text read is consolidated to 24 March 2014, so its annexes are superseded by later règlements even though article 3 is stable, and the instrument as read designates no market surveillance authority. Directive 2011/65/EU Annex I category 8 covers medical devices, Article 4(3) has bound medical devices since 22 July 2014 and in vitro diagnostic medical devices since 22 July 2016, and Article 2(4)(h) excludes active implantable medical devices.
unresolved
loi-2022-weee-producer-register
Registre des producteurs for electrical and electronic equipment
Environmental And Batteries
Mandatory If Feature
Producer Or Authorised Representative
Article 17(1) of the loi of 9 June 2022 on waste electrical and electronic equipment has the Administration de l'environnement keep an electronic register of producers, including distance sellers, and enters in it any producer or mandataire that has obtained its agrément or is a member of an approved organisation and registered as such. Registration is therefore derivative: the substantive gate is the agrément under article 19 of the loi modifiée of 21 March 2012 on waste, not the register entry, and no clause bars market placement for non-registration. Ecotrel asbl is the approved collective organisation for household equipment. Directive 2012/19/EU Article 2(4)(g) excludes devices expected to be infective before end of life and active implantable devices; other medical devices are in scope, and Article 16 requires each Member State to keep a producer register.
unresolved
batteries-regulation-bill-pending
Batteries Regulation producer register pending a national act
Environmental And Batteries
Mandatory If Feature
Battery Producer Or Authorised Representative
Luxembourg has not yet enacted a national Article 55 instrument. The projet de loi relative aux batteries et aux déchets de batteries was still under government amendment as of 19 August 2026; its article 5 would have the Administration de l'environnement establish the register of battery producers required by Article 55 of Regulation (EU) 2023/1542, published electronically on a public website, and would combine the Article 55 registration and Article 58 approval steps as Article 55(8) allows. Today the operative rule is the Regulation itself plus the agrément machinery of the loi modifiée of 21 March 2012, administered by the Administration de l'environnement, with Ecobatterien asbl as the approved collective organisation. Article 11(2)(b) of Regulation (EU) 2023/1542 lets professional medical imaging and radiotherapy devices and in vitro diagnostic medical devices restrict portable-battery replacement to independent professionals, and Article 11(3) lifts the removability duty where continuity of supply is needed for safety or data integrity.
candidate
division-radioprotection-establishment-authorisation
Division de la radioprotection establishment authorisation
Ionizing Radiation
Mandatory For Use Site
Radiation Source Acquisition Holding Or Use
candidate
acceptance-test-and-conformity-finding
Acceptance test and conformity finding before use
Ionizing Radiation
Mandatory If Feature
Radiological Medical Equipment
candidate
EUR-Lex
Low Voltage Directive 2014/35/EU Annex II — electrical equipment for radiology and medical purposes outside scope
https://eur-lex.europa.eu/eli/dir/2014/35/oj
EUR-Lex
EMC Directive 2014/30/EU Article 2(3) — more specific Union legislation displaces the directive
https://eur-lex.europa.eu/eli/dir/2014/30/oj
EUR-Lex
RoHS Directive 2011/65/EU Annex I category 8 and Article 4(3) medical-device application dates
https://eur-lex.europa.eu/eli/dir/2011/65/oj
EUR-Lex
WEEE Directive 2012/19/EU Article 2(4)(g) medical-device exclusions and Article 16 national producer register
https://eur-lex.europa.eu/eli/dir/2012/19/oj
EUR-Lex
Batteries Regulation (EU) 2023/1542 Articles 11 and 55 — medical-device removability derogation and producer register
https://eur-lex.europa.eu/eli/reg/2023/1542/oj
Legilux
Loi modifiée du 27 juin 2016 concernant la mise à disposition sur le marché d'équipements radioélectriques, arts. 7 and 9
https://legilux.public.lu/eli/etat/leg/loi/2016/06/27/n6/consolide/20191227
Legilux
Règlement grand-ducal du 30 juillet 2013 art. 3 — RoHS substance limits (texte coordonné)
https://legilux.public.lu/eli/etat/leg/tc/2014/04/07/n1/jo
Legilux
Loi du 9 juin 2022 relative aux déchets d'équipements électriques et électroniques, art. 17 — register of producers
https://legilux.public.lu/eli/etat/leg/loi/2022/06/09/a266/jo
Legilux
Projet de loi relative aux batteries et aux déchets de batteries, art. 5 — Article 55 register (bill, not law)
https://legilux.public.lu/filestore/eli/dl/pl/2025/226/doc/dpl/1/fr/pdf/eli-dl-pl-2025-226-doc-dpl-1-fr-pdf.pdf
Guichet.lu (Government of the Grand Duchy of Luxembourg)
authorisation for the acquisition, holding or use of radioactive sources or X-ray equipment
https://guichet.public.lu/fr/entreprises/urbanisme-environnement/subst-dangereuses/subst-radioactives/autorisation-detention-sources-radioactives-rayons-x.html
Ministry of Health and Social Security — Division de la radioprotection
acceptance testing and conformity findings for radiological medical equipment
https://santesecu.public.lu/en/espace-professionnel/departement-sante/radioprotection/radioprotection-etablissement-autorisation/etablissements-medicaux/conseils-radioprotection.html
