Approval before the unit arrives
In Luxembourg, buying, fitting, and using an X-ray unit all require advance approval, and for medical X-ray, the Minister of Health authorises each unit. For medical X-ray, this is a class II file. It lists the CE declaration of conformity, the notified-body certificate, and the names of the manufacturer and its authorised representative. The Radiation Protection Division recommends contacting it before a radiation source is acquired, which is why a quote for Luxembourg starts with the papers.
We're MediGear. Our medical equipment distribution business is registered in England and Wales. From there, we provide quotes, documents, and book freight for healthcare buyers in more than 80 countries. For Luxembourg, we look for verified makers of medical instruments and devices whose labels and instructions are in French, German, or Luxembourgish. The points below are checked before any quote reaches your engineers and buying team. No account is required: send requests through the buyers page. Treat this page as a buying note, not a medical guide.
Hospital centres, national centres and laboratories
We welcome requests from buyers such as:
- CHL, HRS, CHEM and CHdN, the four hospital centres
- INCCI, the national reference hospital for heart procedures
- Centre François Baclesse, the national radiotherapy centre, and Rehazenter
- The national health laboratory and private lab networks
- Dental and vet practices with X-ray imaging equipment
- LuxDev, which puts out tenders for its partner countries
- Luxembourg distributors and importers, along with supplies manufacturing companies in Luxembourg
Tenders follow the 2018 public procurement law. Public tenders for the healthcare system in Luxembourg appear on the Portail des marchés publics, where an electronic signature on offers is mandatory. The new CHL Centre building, with 474 beds and 18 operating theatres, should open at the end of 2028, while CHEM's Südspidol is planned to operate from 2033 or later. Even one replacement unit for a dental practice or a hospital centre can be quoted from the model number alone.
Direction de la santé and label languages
The amended Law of 16 January 1990 on medical devices applies alongside the EU rules, and the Direction de la santé is the authority, through its pharmacy and medicines division. Manufacturers' authorised representatives established in Luxembourg register with it, importers established there register through EUDAMED, and distributors have no registration requirement at present. We found no national public device list, so buyers search EUDAMED.
Labels and instructions for users and patients must be in French, German or Luxembourgish. For devices used only by professionals, English is also allowed. We do not import or distribute in Luxembourg and offer no regulatory advice, though each quote sets out the unit's certificates.
Class II, class III and acceptance tests
A law of 28 May 2019 and a regulation of 1 August 2019 cover radiation safety, and it is wise to contact the Radiation Protection Division before acquiring a source. Medical X-ray is class authorised by the Minister of Health, while conventional dental X-ray without 3D imaging is class authorised by the Director of Health. Dental CBCT is classified as class II, and class I and II applications are displayed publicly in the commune for 15 days. An approval lasts from one to ten years, and the process takes a few weeks to several months.
Use may start only after an acceptance test, and the Division hears within three weeks that the results comply. A medical physics expert then runs regular checks, the site runs frequent checks of its own, and average patient dose is checked at least once a year. For dental units, the expert checks CBCT yearly, OPG every three years and intraoral units every six years. Physicians, dentists and veterinarians also need ministerial authorisation to practise radiodiagnosis.
Planned equipment, power and shared records
We settle these points with the maker before we quote:
- Power. Luxembourg runs on 230 V at 50 Hz, and the IEC tables show type C and F plugs. We check that the unit's power supply matches.
- Planned equipment. CT, MRI, mammography, angiography, and similar units are kept for the hospital centres, and a hospital needs the minister's approval before buying one.
- Phantoms and spares. Dental sites run monthly phantom checks, so ask what test tools come with the unit, and spare parts and consumables can ship with it. A consumable such as a surgical mask can be its own line.
- Shared record. The Agence eSanté runs the DSP, the national shared care record, and your IT team can confirm which DICOM and HL7 links the unit needs.
We put open points to the maker in writing first. The X-ray approval file includes inventories of the generator and its associated equipment, so your side will need an equipment and accessory list.
eDouane, EORI and ASTA wood checks. ADA runs customs. A, the Administration des douanes et accises, and import declarations go online through eDouane. The importer needs an EORI number, which an operator from outside the EU can obtain in Luxembourg if it holds no EORI from another EU country. A customs agent must be on ADA's register and based in the EU. Every shipment carries:
- Invoice and packing list per order
- Air waybill, rail note or bill of lading
- Origin documents, where relevant
- HS codes for each item shipped
- CE declaration and certificate
ASTA, the plant protection body, leads wood checks with customs. EU rules apply here: wood packaging arriving from a non-EU country needs the ISPM 15 mark, and failing wood is treated, sent back or destroyed. For goods under specific EU measures, the importer tells ASTA before customs, so we ask makers for heat-treated, stamped crates.
Luxembourg Airport, Bettembourg and Mertert
- Send the request. Provide the model, quantity, and site via RFQ form or email, and indicate whether the approval file is open. If the order spans sites, add a list of hospitals in Luxembourg with the model for each.
- Quote and papers. For catalogue items, quotes for equipment and accessories usually arrive within 48 hours, including certification, lead time, the route, and the papers for the file.
- Written confirmation. The maker gets the order only after your written approval.
- Air, rail or barge. Air freight into the airport cargo centre, rail through the Bettembourg-Dudelange terminal from Antwerp or Zeebrugge, or barge to the Moselle port of Mertert.
Our delivery ends at the destination you nominate, where your representative lodges the import declaration and the last leg becomes yours. Before an X-ray unit leaves the maker, we ask for your approval number. The cargo centre also has a pharma and health centre certified for good distribution practice.
One unit, a new wing or a pre-owned system
Most catalogue lines of medical apparatus can be quoted for one unit, such as a single autoclave for a practice in Esch-sur-Alzette. Dental supplies for a practice are quoted the same way. For a new lab, see laboratory setup, and add its supplies as separate lines. Sterile services teams can browse Sterilisation and Disinfection. A theatre team can send the tower and scope models together for endosvisualization. Our refurbished range covers pre-owned units, and we found no Luxembourg rule aimed at used devices. Refurbished systems follow the same approval, test and planning rules as new medical systems, and each file still needs the CE declaration and certificate. For a like-for-like vet unit, the old unit's acceptance report may be enough within set limits.
Disclaimer
What follows is general information, written for buyers in Luxembourg. It contains no offer to supply and should not be relied on as legal, regulatory or customs advice. Quotes depend on what makers can supply at the time, and nothing is ordered until both sides confirm in writing. Devices need labels in French, German, or Luxembourgish, and X-ray units need advance approval and an acceptance test. Clearance and every regulatory step stay with you and your agent, because we act as neither importer nor distributor in Luxembourg.
Is the authorisation file ready?
Each X-ray unit in Luxembourg is authorised before it is acquired, and the medical X-ray file needs the CE declaration and notified-body certificate. Send the model and the site, and we'll quote with those papers, the label languages and the route.
Frequently Asked Questions
Use the RFQ form on the buyers page or email connect@medigear.uk, including the model number or a specification. There is no account step. We quote medical equipment and supplies for hospital centres, national centres, laboratories, dental and veterinary practices, development agencies and Luxembourg distributors.
French, German or Luxembourgish for the information supplied to users and patients. For devices meant only for professional use, English is also allowed. Active implantable devices need French or German, and we compare the maker's documents with these rules before quoting.
The Minister of Health authorises class II establishments, which covers medical X-ray and dental CBCT, and the Director of Health authorises class III, such as conventional dental and veterinary X-ray. Each radiological unit needs its own authorisation before it is acquired, installed or used.
For medical X-ray, the class II file includes equipment inventories, a risk analysis and shielding calculation, an installation plan and the names of the radiation protection and medical physics experts. For each unit, it also carries the CE declaration and the notified-body certificate.
After the acceptance test, an expert checks CBCT units every year, OPG units every three years and intraoral units every six years. The practice also runs monthly checks with a phantom, and acceptance is repeated only when the unit, the room or the operator changes.
By air into the Luxembourg Airport cargo centre, by rail through the Bettembourg-Dudelange terminal, which links to Antwerp and Zeebrugge, or by barge to the Moselle port of Mertert. Our delivery ends at whichever of these you nominate, and onward transport is yours.
Yes. ADA must recognise a customs representative, which must be entered in its register and established in the EU. Declarations go online through eDouane, and with each consignment we send the invoice, packing list, origin papers, HS codes and the unit's CE file.
Yes. One unit, down to a single medical instrument, is quoted the same way as a larger order on most catalogue lines, and our first reply flags any minimum order from the maker. You will see the lead time and route in the quote, and we will keep you posted by email after dispatch.