Medical devices, your own EU authorised representative company
A maker of medical devices or in vitro diagnostics outside the EU may only place devices on the EU market through a sole authorised representative established in the EU (Medical Devices Regulation (EU) 2017/745, Article 11). That representative is liable for defective devices together with the maker, and from 9 December 2026 it is liable with the maker under the new product liability rules as well. It needs its own person responsible for regulatory compliance in the EU and its own registration in the European database EUDAMED. Makers with a turnover of EUR 10 to 500 million therefore often prefer their own Dutch company as representative and importer. We set it up and do its administration, and a specialist partner provides the regulatory work.
Ask about your situationYour own Dutch company is your authorised representative and your importer at the same time, which the guidance of the Medical Device Coordination Group allows (MDCG 2021-27). Its name goes on the label, it holds the technical documentation and the declaration of conformity, it is registered in EUDAMED with its own single registration number, and it answers the Dutch inspectorate and the other EU authorities.
The representative is liable for defective devices on the same basis as, and jointly and severally with, the maker when a maker outside the EU has failed to comply with its obligations (MDR, Article 11, paragraph 5). For devices placed on the market after 9 December 2026 the representative is also liable with the maker under Directive (EU) 2024/2853, and that liability is unlimited. A company inside your group keeps that risk, the insurance and the records where you control them.
We set up the company, request its registrations, keep its books and file its returns and annual accounts. Our regulatory partner drafts the mandate, provides the person responsible for regulatory compliance that the representative must have at its disposal, and handles EUDAMED. You appoint the directors and see every price first.
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
You own the device and its file, your Dutch company holds the representative and importer roles, and partners provide the PRRC and the specialist work.
Your company
- The device, the technical documentation, the CE certificate and the quality system
- Countries, prices and the distributor model
- The directors of the Dutch company and its business address
The Dutch company
- The Dutch BV as representative and importer, by power of attorney
- KVK, VAT, EORI, the Article 23 licence, eHerkenning and the bank file
- Bookkeeping, VAT returns, annual accounts and the calendar of registrations and renewals
PRRC, EUDAMED, notified body, warehouse
- The person responsible for regulatory compliance, under contract with your Dutch company
- The mandate, the EUDAMED actor and device registrations, the single registration numbers and the UDI
- Contact with the CIBG, the inspectorate and the notified body
- Warehousing for sterile and temperature-controlled devices
Step by step
From a maker with a service representative to a maker with its own EU representative company.
- Your devices and your countries. You describe the devices, their classes, the production site and the countries, and we send a written proposal with the roles and the partners.
- The company. The notary sets up the Dutch BV by power of attorney, and we request the registrations and the Article 23 licence.
- The mandate and the PRRC. Our partner drafts the mandate for the generic device groups, appoints the PRRC under contract with your Dutch company and checks the documentation.
- EUDAMED. Your Dutch company registers as actor with the CIBG, receives its single registration numbers as representative and as importer, and registers the devices before the first sale.
- The label and the switch. The label shows the name and address of your Dutch company, and the previous service representative hands over the records at the end of its mandate.
- Every year. We keep the books and file the annual accounts, and the calendar of EUDAMED confirmations and renewals is kept with your regulatory partner.
What the law asks of your representative
The mandate between you and your representative covers at least the tasks of Article 11, paragraph 3, of the MDR. The representative verifies that the EU declaration of conformity and the technical documentation have been drawn up and that the conformity assessment has been carried out. It keeps a copy of the documentation and the certificates available for the authorities, complies with the registration duties, provides the authorities with the information that shows conformity, forwards requests for samples, cooperates on corrective action and informs you at once about complaints and suspected incidents from healthcare professionals, patients and users.
The mandate covers all devices of the same generic device group, and a maker has one representative per group. The representative must terminate the mandate when the maker acts contrary to its obligations, and then informs the authority of its own member state and the notified body. The same rules apply under the In Vitro Diagnostic Regulation (EU) 2017/746.
The importer, the company that first brings the device into the EU, checks the CE marking, the declaration of conformity, the identification of the maker and the representative, the labelling, the instructions and the unique device identifier (Article 13). Importers register in EUDAMED as well. One Dutch company can be representative and importer for the same device, as long as it meets both sets of duties.
The liability of the representative, twice
Under the MDR, a representative of a maker outside the EU that has failed to comply with its obligations under Article 10 is legally liable for defective devices on the same basis as, and jointly and severally with, the maker (Article 11, paragraph 5). The liability of the maker is established first under the applicable product liability law, and the representative is then liable next to it.
Under Directive (EU) 2024/2853, for devices placed on the market after 9 December 2026, the importer and the authorised representative of a maker established outside the EU are liable for a defective product together with the maker (Article 8), and this time free of the condition that the maker failed its duties. Several liable companies are liable jointly and severally, and a contract clause that limits the liability towards the injured person is void (Article 15). A representative that pays can recover from the maker under national law.
A service company that acts as representative for a fee therefore asks for an indemnity, for insurance that names it as insured and for a yearly fee that reflects the risk, and it keeps the right to end the mandate. Your own company in your group has the same liability, with your insurance behind it, and ends the mandate only when you decide.
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.
The person responsible for regulatory compliance
An authorised representative must have permanently and continuously at its disposal at least one person responsible for regulatory compliance (PRRC) with the qualifications of Article 15 of the MDR, a degree in law, medicine, pharmacy, engineering or another relevant discipline with a year of experience in regulatory affairs or quality management for medical devices, or four years of such experience. The PRRC of the representative is located in the EU and is a different person from the PRRC of the maker, also within one large organisation (MDCG 2019-7, revision 1).
The representative may contract the PRRC from a specialist firm, under a contract that documents the qualifications and the availability. Our partner provides that person for your Dutch company, quotes its own price first and invoices you directly. For makers that are micro or small enterprises, the guidance adds that the PRRC of the maker and the PRRC of the representative must come from different external firms, so our partner takes care that the two roles stay apart.
The Commission proposal of December 2025 to revise the MDR and IVDR is still in the European Parliament, with a plenary vote expected in the first quarter of 2027. According to the summaries of law firms, it leaves the articles on the representative and the importer as they are and would ease the PRRC rules for micro and small makers.
EUDAMED and the Dutch registration
The first four modules of EUDAMED became mandatory on 28 May 2026 under Commission Decision (EU) 2025/2371. Makers, representatives, importers and producers of systems and procedure packs register as actors and receive a single registration number (SRN) per role. A device placed on the market from 28 May 2026 is registered before the first unit is sold, devices that were already on the market are registered by 28 November 2026, and certificates issued before the mandatory date by 28 May 2027. The representative updates its registered data within one week of any change and confirms its accuracy within a year and every two years after that.
In the Netherlands the actor registration goes through the CIBG, the agency of the Ministry of Health, under the authority code NL-CA-058. The applicant creates an EU login, files the registration with the number of its Dutch commercial register entry and its Dutch address, and the CIBG checks that the applicant is based in the Netherlands, usually within 15 days. The Health and Youth Care Inspectorate (IGJ) supervises. The maker reports serious incidents within the deadlines of the MDR, and the representative passes complaints and reports from the EU market to the maker at once.
Our page on medical devices in Europe explains the classes, the transition periods for certificates under the old directives and what changes when your company puts its own brand on a device.
A service representative or your own company
| A service representative | Your own Dutch company | |
|---|---|---|
| Whose name is on the label | The service company, and a change of provider means a change of label, mandate and registration | Your Dutch company, for as long as you sell in the EU |
| Who is liable under Article 11(5) and from 9 December 2026 | The service company, which asks for indemnities and insurance | Your Dutch company, with your group and your insurance behind it |
| The PRRC | The service company’s own person | Contracted from our partner, quoted first |
| Import VAT at the border | Depends on the importer you use | €0 with the Article 23 licence in the name of your company |
| Suits | A small volume, a single device group, a market test | Steady EU sales, with the representative and importer roles in one company of your own |
The whole set-up is on the page your own EU company with a partner that stays.
Why a partner that stays
A representative company is judged over the life of the device. It keeps the technical documentation and the certificates for the period of Article 10, it updates EUDAMED within a week of a change, it passes complaints and incidents to you at once, and it answers the inspectorate in the language of the member state. A missed update or a late report is a finding against your company and your device.
We keep the books, file the annual accounts, maintain the registrations and the Article 23 licence, and keep the calendar of EUDAMED confirmations and renewals, with a reminder to your board when a date comes up. Our regulatory partner does the regulatory work and the PRRC role under its own contract with your company, and your regulatory affairs team keeps the technical side. Your board decides.
Makers from Switzerland, the United Kingdom and the United States
Swiss makers have needed an EU authorised representative since the mutual recognition of medical devices between Switzerland and the EU ended in May 2021, and EU makers need a Swiss representative in turn. UK makers have needed one since 1 January 2021, and the UK asks a UK responsible person of makers outside the UK. A Dutch company holds the EU role only, and local representatives for Switzerland and the UK come from our partners.
US makers that sell through EU distributors can leave the importer role with the distributor and keep the representative role in their Dutch company, or take both roles in the Dutch company and sell to the distributors from there. The second route keeps the label, the records and the liability inside the group, and gives the distributors a European contract party with the Article 23 licence and Dutch stock near Schiphol and Rotterdam.
Sources: Regulation (EU) 2017/745 (MDR), Articles 10, 11, 13, 15, 31 and 87, and Regulation (EU) 2017/746 (IVDR); MDCG 2021-27 rev. 1 on importers and distributors; MDCG 2019-7 rev. 1 on the person responsible for regulatory compliance; MDCG 2022-16 on authorised representatives; Commission Decision (EU) 2025/2371 and the HPRA on mandatory EUDAMED use; Farmatec, applying for a single registration number; Commission proposal COM(2025) 1023, with A&O Shearman on its content and Emergo by UL, 9 October 2026, on its status; Directive (EU) 2024/2853, Articles 8, 12 and 15. Checked on 29 October 2026.
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. Our team replies with advice.
Related guides
The device rules, the set-up and the related roles.