Explore the medical device requirements currently available for Luxembourg, organized by topic and linked to official sources.
Which claims, audiences, channels, approvals, and restrictions apply?
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, alongside MDR Article 7.
What expires, what is retained periodically, and when must renewal start?
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 extended for further periods, each not exceeding five years, based on a re-assessment in accordance with the applicable conformity assessment procedures; any supplement follows the same rules.
Effective from 2021-05-26
Does the event require internal documentation, notice, prior approval, transfer, or a new application?
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 that may affect conformity with the general safety and performance requirements or the prescribed conditions of use require the notified body approval, issued as a supplement to the certificate, and changes to the intended purpose and conditions of use (other than their limitation) necessitate a new conformity assessment application.
Effective from 2021-05-26
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 clinical or IVD performance evidence or study is required and accepted?
notify within 24 hours; report within 3 months
notify within 15 days; report within 3 months
notify within 15 days; summary and report within 1 year (Commission Guideline 2023/C 163/06 template)
Report per MDR Annex XV chapter I section 2.8 and chapter III section 7, with summary.
In Luxembourg, every clinical-investigation application and every substantial modification of a clinical investigation is additionally subject to prior authorisation by the Minister, based on the scientific and ethical opinions of the Direction de la santé and the Comité national d'éthique de recherche (CNER), pursuant to Art. 27 of the Loi du 8 mars 2018 relative aux établissements hospitaliers et à la planification hospitalière.
National legal basis is the hospital law (Loi du 8 mars 2018, Art. 27), not a device-specific law.
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 to recherchebiomedicale@ms.etat.lu and meddevices@ms.etat.lu (Ministry of Health and Social Security). The application dossier may be written in German, French, Luxembourgish or English; proof of insurance covering the project, the number of participants and the whole study duration is mandatory; participant-facing documents (informed consent, questionnaires, recruitment material) must be provided in French and German.
Retrospective studies fall outside the MDR but require CNER ethics approval.
For a substantial modification of a clinical investigation, within one week the applicant informs the ministry of the reasons and nature of the modification and submits the request using the form in Annex I of MDCG 2021-28 to recherchebiomedicale@ms.etat.lu and meddevices@ms.etat.lu, attaching an updated version of the relevant Annex XV Chapter II MDR documentation with the changes clearly visible.
Applicant-side national deadline (stop-clock-like duty) on top of MDR Art. 62-81 procedures.
Is the product a device, IVD, accessory, software, or borderline product locally?
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 beings for one or more specified medical purposes (diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease; diagnosis, monitoring, treatment, alleviation of or compensation for an injury or disability; investigation, replacement or modification of the anatomy or of a physiological or pathological process; or providing information by means of in vitro examination of specimens derived from the human body), and which does not achieve its principal intended action by pharmacological, immunological or metabolic means. Software intended for medical purposes is itself a device.
Effective from 2021-05-26
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 active implantable medical devices, the information to be provided to users and patients must be written in French or German.
National language delta beyond MDR Art. 10(11).
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 PMS plan, report, PMCF or PMPF, trend, and lifecycle-update duties apply?
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 (Art. 84). Class I devices require a post-market surveillance report summarising results and conclusions (Art. 85); class IIa, IIb and III devices require a periodic safety update report (PSUR) per device or category, updated at least annually for class IIb and III devices and at least every two years for class IIa devices, forming part of the technical documentation (Art. 86).
Effective from 2021-05-26
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 QMS, audit, inspection, and certificate scope is accepted or required?
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 effective manner and in a manner proportionate to the risk class and the type of device; the system covers design and manufacture through final inspection and is assessed by the notified body as part of conformity assessment (Annex IX Chapter I).
Effective from 2021-05-26
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.
What review, validation, and applicant stop-clock rules apply?
For clinical investigation applications, the member state must notify the sponsor of the authorisation decision within 45 days of the validation date (Art. 70(5)), extendable by a further 20 days for the purpose of consulting with experts; once notified, and absent a negative ethics opinion valid for the entire member state, the sponsor may start the investigation with the devices referred to in the application.
Effective from 2021-05-26
The fixed statutory clock in the MDR is the clinical-investigation authorisation clock; no statutory review deadline is fixed for notified-body conformity assessment itself.
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.
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.docx); a recent RCS (trade register) extract; the declaration per MDR Annex XIII; applicable conformity certificates; QMS certificate where applicable; labelling and IFU where applicable; and documents demonstrating PRRC qualifications (Art. 15 MDR). They must also submit the list of custom-made devices put into service in Luxembourg.
National registration and documentation delta on top of MDR Annex XIII.
How are deficiencies answered, clocks handled, and decisions escalated or appealed?
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 notified to the applicant, or from the day the applicant could take knowledge of it (loi du 21 juin 1999 Art. 13(1)). A recours gracieux to the competent authority before that period expires suspends the contentieux period, which then starts again from notification of the new decision (Art. 13(2)). If more than three months pass after the recours gracieux without a new decision, the contentieux period starts at the end of the third month (Art. 13(3)). The date of the recours gracieux is proved by the notification of it or by a récépissé from the authority, which must be produced with the tribunal action (Art. 13(3)).
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 initiative from the person concerned, must tell that person by registered letter of the facts and law that lead it to act and must give at least eight days to submit observations, with a right to be heard in person if asked within that period (RGD 8 June 1979 Art. 9). A refusal of a request, a revocation or modification, a decision on recours gracieux, hiérarchique or de tutelle, and a decision that departs from a consultative opinion must be formally motivated (Art. 6). Appeal periods, administrative as well as contentieux, run only from communication of those reasons where motivation is required (Art. 7). A refusal or of-office revocation must also indicate the appeal routes, the time limit, the body to which the appeal is addressed and how it is to be presented (Art. 14).
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?
For any event related to a clinical investigation conducted in Luxembourg, the sponsor notifies without delay to meddevices.vigilance@ms.etat.lu using the form in MDCG 2020-10/2 Rev. 1: (1) any serious adverse event with an established or reasonably conceivable causal link to the device, comparator or investigation procedure — immediately, no later than 2 calendar days after the sponsor becomes aware; (2) any device deficiency that could have led to a serious adverse event, and any new finding on events already reported — no later than 7 calendar days. An initial incomplete report may be submitted to allow timely notification.
National submission channel and deadlines implementing MDR Annex XV / MDCG 2020-10 guidance.
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 Commission website.
National reporting channel beyond EUDAMED (module not yet 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 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).
luxembourg:medical-device
luxembourg
EU MDR classes I, Is, Im, Ir, IIa, IIb and III
National projection of the directly applicable EU MDR classification. The canonical class axis and rules are maintained in eu:medical-device; national references describe only administration or local deltas.
i
Class I
low
is
Class Is
low
im
Class Im
low
ir
Class Ir
low
iia
Class IIa
medium
iib
Class IIb
high
iii
Class III
highest
Direction de la santé
official-source-verified
Direction de la santé — Dispositifs médicaux (Portail Santé, mise à jour du 20/07/2026)
https://santesecu.public.lu/fr/espace-professionnel/departement-sante/pharmacies-et-medicaments/dispositifs-medicaux.html
2026-08-29
Luxembourg publishes no national class axis: the page states that Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR) apply, so MDR Annex VIII classification governs directly. National delta: before placing a Class I device or an IVD on the market, a manufacturer or authorised representative established in Luxembourg must register it with the Direction de la santé, and since EUDAMED became mandatory Luxembourg accepts EUDAMED registration as satisfying that national requirement.
Loi modifiée du 16 janvier 1990 relative aux dispositifs médicaux, version consolidée applicable au 25/08/2018, art. 1er et 2
https://legilux.public.lu/eli/etat/leg/loi/1990/01/16/n1/consolide/20180825
2026-08-29
The still-in-force national framework law places marketing, import, advertising and use of medical devices under the supervision of the ministers responsible for Health and Justice (art. 1er) and delegates any national division of devices into classes to a règlement grand-ducal (art. 2); no such grand-ducal regulation establishes a class axis competing with MDR Annex VIII.
eu:medical-device
Regulation (EU) 2017/745, Art. 51 and Annex VIII
https://eur-lex.europa.eu/eli/reg/2017/745/oj
2026-08-29
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
✅
No maintained record.
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
