Medical devices in Europe: the representative, the importer and the database
A medical device from outside the EU needs two European names before it is sold: an authorised representative and an importer. Since 28 May 2026 both must be registered in the EU database. Many manufacturers hire a service company for this. Those with real sales set up their own European company. This page shows both.
Ask about your situationMedical devices sold in the EU fall under the Medical Device Regulation (MDR) or, for tests on samples such as blood, the In Vitro Diagnostic Regulation (IVDR). A manufacturer outside the EU must appoint an authorised representative that is established in the EU, and its devices must enter through an importer that is established in the EU. Both are registered in the European database for medical devices (EUDAMED), which is mandatory since 28 May 2026. Holdwise sets up the Dutch company that can be the representative and the importer, and coordinates the regulatory work with specialist partners.
On this page: what the representative and the importer do, what changed in 2026, when your own company is the better choice, and the steps from your first question to the first shipment.
Two European names on your device
The authorised representative. A manufacturer that is established outside the EU must appoint one authorised representative in the EU before it places a device on the market. The representative is named on the label and in the instructions for use. It keeps a copy of the technical documentation and the EU declaration of conformity, answers the authorities, and is legally liable together with the manufacturer for defective devices. It must have at least one person responsible for regulatory compliance (PRRC) with the right qualifications.
The importer. The company that first brings the device into the EU must also be established in the EU. Before it sells, the importer checks that the device has the CE marking, that the declaration of conformity exists, that the manufacturer has a representative, and that the labelling and the unique device identifier (UDI) are in order. The importer’s name and address go on the device, the packaging or a document that comes with it.
These two roles can be two different companies. They can also be one company: your own Dutch subsidiary that acts as representative and as importer. Distributors, the companies that sell on to hospitals and shops, have lighter duties and can be anywhere in the EU.
What changed in 2026
On 27 November 2025 the European Commission published the notice that four modules of EUDAMED are functional. Six months later, on 28 May 2026, their use became mandatory. Every manufacturer, authorised representative, importer and system or procedure pack producer must now be registered in the actor module and hold a single registration number (SRN). A manufacturer outside the EU registers through its authorised representative; the representative confirms the mandate and the national authority then issues the SRN.
Devices placed on the market from 28 May 2026 are registered in the device module before the first unit is sold. Devices that were already on the market before that date must be registered by 28 November 2026. Certificates from notified bodies are registered too.
The transition for older devices continues. Certificates issued under the old directives remain valid until 31 December 2027 for class III and class IIb implantable devices, and until 31 December 2028 for the other classes, provided the manufacturer has a quality system in place and has applied to a notified body in time.
A service company or your own European company
A representative service costs a fixed fee per year and works well for a company that tests the market with a small volume. The service company is on your label, holds your documents and answers the authorities. When you change service provider, the label, the registrations and the mandate change with it.
Your own Dutch company is the choice for a manufacturer with real sales in Europe. The representative and the importer are then one company that you own. Your name is on the label. The technical documentation stays inside your group. Contracts with distributors and hospitals are signed by your company. Stock is held in the Netherlands, and with the Article 23 licence you pay no import VAT at the border. The person responsible for regulatory compliance can be an employee or a contracted specialist in the first years.
The Dutch registration is done at Farmatec, the licensing office of the Ministry of Health, which keeps the national register of manufacturers, representatives, importers and distributors. The inspectorate is the Health and Youth Care Inspectorate (IGJ). The notified bodies for CE marking are private organisations; the Netherlands has several, including BSI in Amsterdam and DEKRA in Arnhem.
The Netherlands as a base for medical technology
The country has the European Medicines Agency in Amsterdam, notified bodies for the MDR and the IVDR, university medical centres in eight cities and a logistics cluster around Schiphol and Rotterdam that handles temperature-controlled and sterile goods every day. English is the working language at the tax office and the trade register.
A Dutch company pays 19% corporate tax on the first €200,000 of profit and 25.8% above that. Profit that comes from your own patented technology can qualify for the innovation box at 9%. Dividends to a parent company in a treaty country usually go out without Dutch dividend tax. Read more on setting up a subsidiary in Europe.
Based on Regulation (EU) 2017/745 (MDR), Regulation (EU) 2017/746 (IVDR), Regulation (EU) 2023/607 on the transition periods, Commission Decision (EU) 2025/2371 on EUDAMED and the registration pages of Farmatec, as applied in September 2026. Regulatory files are prepared by specialised partners; Holdwise coordinates.
Who does what
Holdwise sets up and runs the Dutch company and stays your single point of contact. Specialist partners do the licence and product work. You keep one contact, one file and one invoice.
Your company
- Own the device, the technical documentation and the CE certificate
- Keep the quality management system at the factory
- Decide the countries, the price and the distributor model
- Sign the power of attorney and the mandate for the representative
The Dutch base
- Sets up the Dutch company (a BV), by power of attorney, with the notary
- Registered office, KVK number, tax number and VAT number
- Bank account, the customs number (EORI) and the Article 23 licence
- Bookkeeping, VAT returns, annual accounts and corporate tax
- Single point of contact for the regulatory partner and the warehouse
Licences and product rules
- The representative mandate and the person responsible for regulatory compliance
- EUDAMED actor and device registration, the SRN and the UDI
- Farmatec registration and contact with the inspectorate
- Notified body contact, technical file reviews, ISO 13485 support
- Warehousing and distribution for sterile and temperature-controlled devices
The route, step by step
What happens from your first question to the day your first product is on the European market.
- One question. You tell us what the device is, its class, where it is made and which countries you want to sell in. We answer in writing with the structure that fits and one written proposal.
- The Dutch company. The notary sets up the BV by power of attorney with the parent as shareholder. You receive the KVK number, the tax number, the VAT number and the customs number. The bank file starts on day one.
- The mandate. The Dutch company becomes your authorised representative and importer. The regulatory partner drafts the mandate, appoints or contracts the person responsible for regulatory compliance and checks your technical documentation.
- The registrations. Actor registration in EUDAMED, the single registration number, the device registration with the unique device identifiers, and the Dutch registration at Farmatec.
- The label. The name and address of the representative and the importer go on the device, the packaging and the instructions. The partner checks the labelling before the first shipment.
- Operations. Stock in a Dutch warehouse, sales to distributors and hospitals across the EU from your own company, VAT and bookkeeping done. One monthly overview, one point of contact.
Related guides
The other parts of the route to Europe, on the same site.
Common questions
Ask about your own situation
Tell us what you make or sell, where your company is and which countries you want to sell in. You get a written answer. Where a Dutch company fits, we write down what it would look like and what it costs.
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