Medical devices in Europe: the representative, the importer and the database
A manufacturer from outside the EU or the European Economic Area (EEA) needs an authorised representative and an importer in the EU or the EEA before it can sell a medical device there, and since 28 May 2026 both must be registered in the EU database for medical devices. Many manufacturers hire a service company for these roles, while those with real sales in Europe set up their own European company.
Ask about your situationMedical devices sold in the EU fall under the Medical Device Regulation (MDR), which also applies in Norway, Iceland, Liechtenstein and Northern Ireland, while tests on samples such as blood fall under the In Vitro Diagnostic Regulation (IVDR). A manufacturer outside the EU or the EEA must appoint an authorised representative established in the EU or the EEA, and its devices must be imported by an importer established there as well. Since 28 May 2026 both must be registered in the European database for medical devices (EUDAMED).
We set up the Dutch company that can act as both representative and importer, and we coordinate the regulatory work with specialist partners.
Tell us what you make or sell, where your company is and what you plan in Europe. Our team looks at it and replies with the steps and the dates that apply to you.
Who does what
We set up and manage the Dutch company. Specialist partners do the licence and product work. We are your only contact, with one file for all the work.
Your company
- Own the device, the technical documentation and the certificate for the European conformity marking (CE)
- 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 company
- Set up the Dutch private limited company (BV) by power of attorney, with the notary
- Chamber of Commerce number (KVK), tax number and VAT number
- Bank account, the EU customs number (EORI) and the Dutch licence to defer import VAT (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, a single registration number (SRN) for each role and the unique device identifier (UDI)
- Contact with Farmatec, the Dutch government office that registers medical device companies, and the inspectorate
- Notified body contact, technical file reviews and support with the quality standard for medical devices (ISO 13485)
- Warehousing and distribution for sterile and temperature-controlled devices
The steps to the European market
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 reply with a suitable structure and a 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. We prepare the bank application.
- 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. The Dutch company is registered as an actor in EUDAMED. Farmatec approves it, and the company receives a single registration number (SRN) for each role. Your devices are registered with their unique device identifiers.
- The label. The name and address of the representative go on the label. The name and address of the importer go on the device, the packaging or a document that comes with it. The partner checks the labelling before the first shipment.
- Operations. Your stock is kept in a Dutch warehouse and your own company sells to distributors and hospitals across the EU. We handle the VAT and the bookkeeping, and you receive one monthly overview from one contact person.
The authorised representative and the importer
A manufacturer established outside the EU or the EEA must appoint one authorised representative in the EU or the EEA before it places a device on the market. The representative is named on the label (MDR Annex I, 23.2 d), keeps a copy of the technical documentation and the EU declaration of conformity, and answers the authorities. It is liable for defective devices together with the manufacturer, but only when the manufacturer fails to meet its duties (Article 11(5)). 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 or the EEA, must also be established there. Before it sells, the importer checks that the device has the CE marking and a declaration of conformity, 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 (Article 13(3)).
Two different companies can take these roles, or one company can take both, for example your own Dutch subsidiary. Distributors, the companies that sell on to hospitals and shops, have lighter duties and can be based anywhere in the EU.
EUDAMED registration became mandatory in 2026
On 27 November 2025 the European Commission published the notice that four modules of EUDAMED are functional, and 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. Each role has its own single registration number (SRN), so a company with both roles has two. A manufacturer outside the EU registers through its authorised representative, which confirms the mandate, after which the national authority 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.
Older devices remain in a transition period. Certificates issued under the old directives remain valid until 31 December 2027 for class III and class IIb implantable devices, with the exception of class IIb implantable devices such as sutures, staples, screws and plates. For those, and for the other classes, the certificates remain valid until 31 December 2028. These dates apply only if the manufacturer has a quality system in place and applied to a notified body in time.
Tell us what you make or sell, where your company is and what you plan in Europe. Our team looks at it and replies with the steps and the dates that apply to you.
A service company or your own European company
A representative service costs a fixed fee per year and suits a company that tests the market with a small volume. The service company’s name appears on your label, it keeps your documents and it answers the authorities, so a change of service provider also means a new label, new registrations and a new mandate.
Your own Dutch company suits a manufacturer with real sales in Europe, because the representative and the importer are then one company that you own. Your name appears on the label, the technical documentation stays inside your group, and your company signs the contracts with distributors and hospitals. Stock is kept in the Netherlands, and with the Article 23 licence the company pays €0 import VAT at the border and reports the VAT in its VAT return. In the first years, the person responsible for regulatory compliance can be an employee or a contracted specialist.
Registration takes place in EUDAMED, and in the Netherlands it is approved by Farmatec, part of the licensing agency of the Ministry of Health (CIBG). The Health and Youth Care Inspectorate (IGJ) supervises the market. The notified bodies for CE marking are private organisations, and the Netherlands has several, including bodies in Amsterdam and Arnhem.
The Netherlands as a base for medical technology
The Netherlands hosts the European Medicines Agency in Amsterdam and notified bodies for the MDR and the IVDR, along with seven university medical centres in seven cities. Logistics companies around Schiphol and Rotterdam handle temperature-controlled and sterile goods every day. The tax office and the trade register work in Dutch, and both give some information in English.
A Dutch company pays 19% corporate tax on the first €200,000 of profit and 25.8% above that. Profit from research and development that the Dutch company does itself can qualify for the innovation box, a reduced rate of 9%, provided the company has a research and development declaration (S&O-verklaring) from the Netherlands Enterprise Agency (RVO). A patent of the parent company is excluded. Your company can usually pay dividends to a parent company in a treaty country free of Dutch dividend tax. Read more on setting up a subsidiary in Europe.
Monitoring the device after the first sale
After the device is sold, the manufacturer keeps a plan for monitoring it on the market, known as post-market surveillance. For devices in the higher classes, the manufacturer records the results in a periodic safety update report. A serious incident with a device in the EU must be reported to the national authority within 15 days, within 10 days when a patient died or was seriously harmed, and within 2 days when there is a serious threat to public health. In the Netherlands, the manufacturer sends the reports to the IGJ, and once the EUDAMED module for this is in use, the reports go through EUDAMED.
The authorised representative receives complaints and reports from the EU market and passes them on to the manufacturer. If that representative is your own Dutch company, the reports stay in your group and you answer the authorities yourself.
When the importer becomes the manufacturer
An importer or distributor that only checks and forwards the device has light duties, and your company takes on more when it changes the device or its presentation. If your Dutch company puts its own name or brand on the device, it becomes the manufacturer under the regulation, with the full duties, including the technical documentation, CE marking under its own name and a person responsible for regulatory compliance. If your company changes the label, the instructions or the packaging, for example by adding a Dutch or German translation, it needs a quality system for that work, certified by a notified body, and it must inform the manufacturer and the authority 28 days before it starts.
Most manufacturers keep the CE marking with the factory, so the Dutch company acts only as representative and importer. Each company then has its own duties, and the documentation is kept in one place.
The United Kingdom and Switzerland
The United Kingdom accepts the CE marking for medical devices for the time being, and a manufacturer based outside the United Kingdom needs a UK Responsible Person there. Switzerland has stopped recognising the EU representative automatically, so a manufacturer outside Switzerland needs a Swiss authorised representative, whose name also goes on the label. Your Dutch company can take the EU role, while for the United Kingdom and Switzerland you appoint a local representative or a service company.
Buyers in countries outside the EU often ask for a certificate of free sale when you export from the Netherlands. Farmatec issues that certificate for CE-marked devices of manufacturers and representatives that are registered in the Netherlands.
Based on Regulation (EU) 2017/745 (MDR), Regulation (EU) 2017/746 (IVDR) and Regulation (EU) 2023/607 on the transition periods. Also based on Commission Decision (EU) 2025/2371 on EUDAMED and the registration pages of Farmatec. All as applied in September 2026. Specialised partners prepare the regulatory files, and we coordinate their work.
Common questions
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Tell us what you make or sell, where your company is and which countries you want to sell in. Our team replies with advice.
Related guides
More guides about selling in Europe.