Conformity checks at first acquisition
In the Dutch healthcare system, a care provider must check that a device meets EU rules each time it first acquires one, whether by purchase, loan or lease. The Health and Youth Care Inspectorate (IGJ) expects the check to be recorded, and a generic check at maker or supplier level is not enough. A unit shipped from Great Britain is also a non-EU import, so who holds the importer's role is for the hospital and its advisers to determine. That is why our quotes for the Netherlands begin with the CE file.
We work under the MediGear name as a distributor of medical equipment, from a company registered in England and Wales. Healthcare buyers in more than 80 countries send us requests for medical devices and supplies, and we respond with quotes, documents, and freight. For the Netherlands, we look for verified makers whose labels and instructions come in Dutch, or in English where only professionals use the device. We settle each point below before the quote reaches your medical technology team. There is nothing to sign up for: the buyers page takes your request.
University centres, general hospitals and focus clinics
We quote for hospitals in the Netherlands and other Dutch care providers, from the seven university medical centres to single practices:
- Amsterdam UMC, at its AMC and VUmc locations
- Erasmus MC in Rotterdam and UMC Utrecht
- Radboudumc in Nijmegen and UMCG in Groningen
- General hospitals such as TTergoeMC, and endoscopy units
- Independent clinics in ZKN, at nearly 440 locations
- Dentists and vets who run their own X-ray units
- Dutch importers, distributors and service firms
Public tenders by Dutch authorities follow the Public Procurement Act 2012, and every Dutch authority must publish its tenders on TenderNed, the government's online tendering system. Since February 2026, the field norm for hospitals has been a guide on medical technology, which requires a programme of requirements before a purchase. Two examples from the health system in the Netherlands: UMCG is expanding and renewing its sites through 2035, and the Diakonessenhuis in Utrecht plans a new building with radiology and nuclear medicine, with work due in 2027. A single practice with one unit to replace only needs to send the model number.
IGJ, Farmatec and Dutch texts
The Medical Devices Act of 2019 applies alongside the EU regulation to medical devices. IGJ inspectors supervise both devices and their safe use across healthcare in the Netherlands. CIBG and Farmatec, an agency of the health ministry, are the Dutch authority that registers economic operators in EUDAMED, and importers have had to register there since 28 May 2026. National notification in NOTIS covers class I, custom-made and IVD devices from makers or representatives based in the Netherlands. We found no Dutch registration for distributors or for foreign suppliers that sell medical devices in the Netherlands.
Dutch is the required language for labels and instructions. English is allowed for devices used only by professionals, as long as the maker makes sure those users read English well enough. Our part ends at supply: for Netherlands distribution we hold no Dutch importer or distributor role and give no regulatory advice, though the quote names every certificate the unit carries.
ANVS permits, registrations and acceptance
Radiation falls to ANVS, the Authority for Nuclear Safety and Radiation Protection, under the Nuclear Energy Act and a 2017 decree on basic safety standards. Among diagnostic imaging devices, X-ray units used on people need an ANVS permit unless the use fits a registration category. These cover dental X-ray at a fixed location, some veterinary imaging units, and population screening, but exclude computed tomography. ANVS asks for a registration request at least eight weeks before first use. Permit timing depends on the procedure, and for a dental permit ANVS says to plan at least 14 weeks.
Installing, dismantling, repairing, servicing, and quality-testing an X-ray unit requires its own permit, so check who will fit the unit before it ships. Storing X-ray units for trade needs registration. Radiation protection experts register with ANVS and renew every five years. We could not read the decree's chapter on equipment, so we found no national test interval. EU rules require an acceptance test before first clinical use and regular tests after that, and we send the maker's schedules with the quote.
230 V, Dutch texts and planned maintenance
Before a quote goes out, the maker answers these points:
- Mains and plug type. Dutch sites take 230 V at 50 Hz, with type C and F plugs in the IEC tables, so we match the power module to both.
- Dutch or English texts. Lay-use devices need Dutch, while professional-use devices may carry English, so we check the label and instructions with the manufacturer.
- Maintenance plan. The field guide lists preventive maintenance in the device overview, so we ask for the service schedule, and spare parts and consumables can ship with the unit.
- Requirements programme. Send your requirements programme, and we will check each line with the manufacturer before quoting.
Open points go to the maker in writing first, because your conformity check rests on the papers we send.
DMS, AGS and NVWA wood checks
Dutch Customs, the Douane, takes import declarations electronically in DMS or AGS. The importer can declare itself or use a representative, who must be established in the EU and, in the Netherlands, meet the AEO criteria. Our file for a Dutch order holds:
- Commercial invoice with a matching packing list
- Transport papers: the bill of lading or air waybill
- Origin details the declarant asks for
- An HS code on each invoice line
- The CE declaration and notified-body certificate
Packing wood and dunnage from outside the EU must be treated and marked under ISPM 15. The NVWA enforces this, and KCB inspectors check notified consignments by sampling. Wood that fails is refused, and the importer must return it, re-treat it, or have it destroyed; wood with a quarantine pest can only be returned or destroyed. That is why we ask manufacturers to ship in heat-treated, stamped crates.
Rotterdam, Schiphol and the road to site
- Model and requirements. Send the model, quantity, and site via RFQ form or email, with your programme of requirements if you have one.
- Quote with the CE file. Catalogue items are usually quoted within 48 hours, and the quote shows certification, lead time, the route and the papers for your check.
- Approval in writing. Your written go-ahead on the quote is what triggers the order with the maker.
- By sea or by air. Sea freight goes into the Port of Rotterdam, which handled 323.2 million tonnes in the first nine months of 2026, and air freight goes into Schiphol, where medical equipment is a key cargo.
Delivery ends at the port or airport you nominate, where your declarant lodges the import declaration in DMS or AGS. The last leg to site is yours, and before mammography equipment or another X-ray unit leaves the maker, we ask who holds the ANVS permit to install it.
One monitor, a new building or refurbished medical equipment
Single items are welcome too: a practice in Nijmegen can request one patient monitor or one item of imaging equipment from most catalogue lines. For a new department, see hospital setup, and digital health teams can browse Smart Devices. Our refurbished range includes pre-owned units, and our search found no Dutch ban or rule on second-hand or refurbished medical devices. Used and refurbished equipment from the UK must still meet EU rules when it first enters the EU market, and the hospital checks its conformity like any other first acquisition. Refurbished equipment providers should note that, under EU rules, whoever fully refurbishes a device counts as its manufacturer.
Disclaimer
Treat this page as general background for Dutch buyers: it makes no offer to supply and is not legal, regulatory or customs advice. What we can quote depends on the manufacturer, and an order exists only once both sides confirm it in writing. Devices need Dutch texts or, for professional use only, English, and X-ray units need an ANVS permit or registration before use. We are not a Dutch importer or distributor, so customs clearance and the regulatory checks stay with you and your declarant.
Has procurement checked the CE file?
IGJ expects Dutch care providers to record an EU conformity check at each first acquisition, and a generic check at supplier level does not count. Send the model and the site, and we'll quote with the CE declaration, the certificates and the route.
Frequently Asked Questions
Through the RFQ form on the buyer's page or by email to connect@medigear.uk, with a model number or a specification. No account is needed, and replies come by email. We quote for hospitals Netherlands-wide, from university medical centres to independent clinics, dental and veterinary practices and Dutch importers.
IGJ expects the provider to check that the device conforms to EU rules at every first acquisition, whether by purchase, loan or lease, and to record that check. Procurement may do it centrally for the whole hospital, but a generic check at manufacturer or supplier level is not enough.
Yes, if the device is meant only for professional users and the maker makes sure those users read English well enough. Devices for lay users need Dutch labels and instructions. The rule comes from the ministerial regulation that sits under the Medical Devices Act.
ANVS, the Authority for Nuclear Safety and Radiation Protection. Most diagnostic X-ray units need a permit, while dental units at a fixed location, some veterinary units and screening units other than CT need registration. Apply at least eight weeks in advance for registration, and plan longer for a permit.
Only a holder of an ANVS permit for that work. The decree makes installing, dismantling, repairing, servicing, and quality-testing X-ray equipment a permit activity in its own right, so check who will fit the unit before it ships. Storing X-ray units for trade needs registration.
Yes. Goods from outside the EU, including Great Britain, are declared electronically in DMS or AGS by the importer or by a representative based in the EU who, in the Netherlands, meets the AEO criteria. We send the invoice, packing list, transport papers, HS codes and the unit's CE file with each order.
Yes, most catalogue lines can be quoted for one unit, and if the maker sets a minimum order, the first reply says so. The practice also needs ANVS registration, or a permit for cone-beam CT systems or mobile use, before the unit goes into use.
Mostly the paperwork: the CE file for your conformity check, Dutch texts for lay-use devices and, for medical imaging, the ANVS permit or registration for X-ray. Wood packaging without the ISPM 15 mark is refused at the border. The quote states the lead time and the route.