One federal law, enforced in the Länder
Medical device law in Germany is federal, but most of the enforcement is not. The Medical Devices Implementation Act (MPDG) makes the Länder authorities competent unless it says otherwise. X-ray notices also go to a Land office. So start by finding out which office will deal with your unit. Then ask who will run its acceptance test before the first patient.
We're MediGear. For healthcare buyers in more than 80 countries, we quote, document, and ship certified equipment as a medical equipment distributor registered in England and Wales. Send us a model or a clinical need, and tell us whether it's from a German manufacturer. We look for verified manufacturers who can supply it. Then we check the points on this page. The quote that comes back is written for your clinical engineers and purchasing department. Our buyers page takes the request, and you won't need an account.
Hospitals, groups and practices that ask us
Requests for medical equipment in Berlin, Hamburg, Munich and beyond come from a wide spread of buyers:
- University hospitals such as Charité in Berlin, UKE in Hamburg and LMU Klinikum in Munich, whose new children's hospital topped out in September 2025
- Private hospital groups, among them Helios, Asklepios, Sana and AMEOS
- Outpatient practices and specialist clinics
- Medical laboratories, which have their own quality assurance section in the operator ordinance, and suppliers of laboratory equipment
- Dental and veterinary practices with X-ray units of their own
- The Bundeswehr, whose devices have a section of their own in the same ordinance
- Importers and medical device distributors in Germany
Public tenders above the EU thresholds follow Part 4 of the GWB competition act and the VgV. Smaller contracts fall under the UVgO or the procurement law of each Land. An act to speed up tendering, in force since 1 July 2026, lets more of those steps happen online. A private practice replacing one ultrasound scanner needs a clear quote and a date. Say which applies, and we'll shape the quote to it.
BfArM, the MPDG and German-language information
The Federal Institute for Drugs and Medical Devices (BfArM) in Bonn is the federal authority. The 2020 MPDG brings the EU Medical Devices Regulation into effect. Section 8 of the act sets the language: information for users and patients must be in German. In justified cases, material intended only for professional users may be in English, provided the safety information is also in German. BfArM's guidance on DMIDS and importers explains who registers where.
German importers register only in EUDAMED. BfArM says there is no legal basis for an importer registration in its national system. A CE-marked device already registered in another EEA state needs no separate German notice either. Because the importer must be established in the EU, a German hospital buying straight from the UK should work with its own advisers, who hold that role. We are not a German importer and do not give regulatory advice. Each quote lists the unit's certificates for your team to check.
Notifying an X-ray unit to the Land authority
Under the Radiation Protection Act, a CE-marked medical X-ray unit is normally run on written notice to the Land authority, made at least two weeks before use starts. A licence is needed instead for teleradiology, screening, mobile X-ray rooms, or a room an expert has not checked for that unit, as set out in section 19 of the Act. The notification must include an authority-appointed expert's certificate, which also confirms the acceptance test.
The manufacturer or supplier of the components carries out that test, with your radiation protection officer involved. It also fixes the reference values for later constancy checks. The expert inspects the unit again at least every five years. Work on humans must also be reported to the medical body the authority names. Firms that service X-ray units commercially notify the authority before starting. Agree in writing who will run the acceptance test while the quote is still open.
MPBetreibV checks and other specification points
The 2025 operator ordinance shapes several points we settle with the maker:
- Power and plugs. Sockets here take type C and F plugs on a 230 V, 50 Hz supply. A unit designed for 110 V or 60 Hz should be flagged early, as it may need another factor buildy.
- Safety checks. Devices in the ordinance's first annex, such as defibrillators, ventilators and MRI scanners, need a functional test on site and staff instruction by the manufacturer or a person it authorises before first use. Safety checks then follow at least every two years.
- Measuring functions. Non-invasive blood pressure monitors are among the devices that need measuring checks every two years. Our quote can include the spare parts and consumables you are likely to reorder.
- ePA and the network. The ePA, the German healthcare system's electronic patient record, was rolled out nationwide in April 2025. Hospitals in Germany and other providers have had to use it since October 2025, so check DICOM, HL7 and record links with your IT team.
Open points go to the maker before the quote is written, since a question settled now is quicker than one raised by the expert at the inspection.
Papers for Zoll and the plant protection service
For goods from outside the EU, the customs declaration goes through ATLAS, and the declarant must be established in the EU or represented by someone who is. Each order ships with:
- An invoice that matches the packing list line for line
- The certificate of origin your declarant asks for
- Customs commodity codes, line by line
- The declaration of conformity, in German or English
- User information in German, plus the radiation safety documents the maker must supply
Wood packaging from outside the EU must meet ISPM 15 under the EU plant health regulation. The Julius Kühn-Institut coordinates this nationally, and the plant protection services of the Länder carry out the checks. Some consignments from listed third countries must also be notified in advance, so we ask makers for treated, stamped crates from the outset.
Ordering for Hamburg, Bremerhaven or Frankfurt
- Write in. Give the model, quantity and site by RFQ form or email, and say who will declare the goods.
- Check it against the tender. Catalogue quotes usually arrive within 48 hours and state the CE certificates, lead time, and port so they can sit in your procurement file beside the other offers you hold.
- Confirm the order. An email or letter from you makes the quote binding on both sides.
- Ports and air cargo. Sea freight into Hamburg, Bremerhaven or the JadeWeserPort deep-water terminal in Wilhelmshaven, or air freight through Frankfurt for smaller or urgent items.
Your declarant, established in the EU, lodges the import declaration in ATLAS once the goods reach the port or airport you nominate. The road leg to the hospital is then yours to arrange. In snow, ice or slush, lorries may only run on suitable tyres, which is worth planning for on Alpine routes in winter.
From one monitor to a new building
Most catalogue lines can be quoted as one unit, so a practice replacing a single monitor or a clinic adding mobile X-ray equipment can order just that. We also quote multi-line requests for hospital groups and new buildings; see private tender for group purchases, and eye and ENT departments can browse ENT, Ophthalmic and Sensory. Our refurbished range covers refurbished medical devices and other pre-owned units. We found no German rule written just for used medical equipment. Even so, the operator and radiation rules still apply once a unit goes back into service, and an MRI scanner needs its on-site functional test by the manufacturer or someone it authorises.
Disclaimer
The guidance here is general and written for buyers in Germany. We make no offer to supply on this page, and none of it is legal, regulatory or customs advice. What we can quote depends on what makers can supply, and an order binds both sides only once it is agreed in writing. A device's status depends on its CE certificates and intended use, and an X-ray unit also needs notification or a licence under the Radiation Protection Act. Import clearance and the regulatory status of your purchase are your responsibility, and we do not act as an importer in Germany.
Planning a new X-ray room?
X-ray equipment, new or refurbished, usually needs an expert's certificate before the first patient, so it helps to start early. Email the model number or a data sheet, and we'll quote with the acceptance test and the route into Germany set out.
Frequently Asked Questions
Through the RFQ form on the buyer's page or by email to connect@medigear.uk, including the model or specifications; no account is required. A list you have already sent to suppliers in Germany will do. It can include medical consumables as well as equipment. The quote comes back by email.
German, for information given to users and patients. In justified cases, information meant only for professional users may be in English, provided the safety information is also in German or the user's language. The declaration of conformity itself may be in German or English.
No. BfArM says German importers register only in EUDAMED, and there is no legal basis for a registration in its national system. Because the importer must be established in the EU, German hospitals buying directly from the UK should check with their own advisers before ordering.
Usually, a written notification to the Land authority at least two weeks before use, plus a certificate from an authority-appointed expert confirming the acceptance test. Teleradiology, screening, mobile rooms or an unchecked room need a licence instead. If the expert needs technical data on the tube or X-ray detectors, we get it from the manufacturer.
Sea freight goes into Hamburg, Bremerhaven or Wilhelmshaven, while smaller medical diagnostic equipment and urgent items can fly into Frankfurt. Clearance by your declarant and the last leg to your hospital or practice follow delivery at the point you nominate, so say early if the site is hard to reach.
Only if you are established in the EU, or through a representative who is; customs may make an exception for occasional declarations (fewer than ten a year) if it considers that justified. Declarations go through ATLAS. We supply the invoice, packing list, origin documents, commodity codes and CE paperwork.
Yes. Ultrasound and other diagnostic imaging equipment can be quoted as single units on most catalogue lines. We tell you at once if a manufacturer sets a minimum order quantity. For a site with narrow access or a winter mountain road, mention it, and we will ask for packing to match.
Mainly the maker's stock, whether you choose new or refurbished medical equipment, where it ships from and how it travels. We give the lead time and route in the quote and email you at dispatch and as the shipment moves.