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Under the EU MDR, Regulation (EU) 2017/745, a manufacturer outside the EU can only sell medical devices on the Dutch market through a sole authorised representative in the Union. Legacy devices have until 31 December 2027 or 2028. This page is for manufacturers in the UK, the US, Switzerland and Asia and their Dutch importers: your duties, and which contracts to have reviewed.
Position as at October 2026, based on the consolidated text of the MDR of 19 July 2026.
When does the EU MDR apply and which Dutch rules come on top?
The Medical Device Regulation (MDR) has applied directly in every Member State, including the Netherlands, since 26 May 2021. The Dutch Medical Devices Act (Wet medische hulpmiddelen) adds rules on supervision, language and sanctions.
Article 123(2) MDR sets that date. The Dutch Medical Devices Act (in Dutch) implements the Regulation. The MDR contains the product requirements; Dutch law decides who enforces them. For other product rules, see our overview of product compliance in the Netherlands.
Which MDR transition dates apply to legacy devices?
A device with a still valid certificate under Directive 93/42/EEC (MDD) or 90/385/EEC can go on the market until 31 December 2027 or 31 December 2028, depending on its risk class. The conditions in Article 120(3c) must also be met.
Regulation (EU) 2023/607 introduced these dates. The table follows the consolidated text.
| Device group | Provision | Placing on the market allowed until |
|---|---|---|
| Class III devices and class IIb implantable devices (except, among others, sutures, staples, dental fillings, screws, plates, wires and pins) | Art. 120(3a)(a) | 31 December 2027 |
| Other class IIb devices, class IIa devices, and class I devices that are sterile or have a measuring function | Art. 120(3a)(b) | 31 December 2028 |
| Devices that needed no notified body under the MDD (declaration of conformity before 26 May 2021) but need one under the MDR | Art. 120(3b) | 31 December 2028 |
| Class III custom-made implantable devices without an MDR certificate | Art. 120(3f) | Expired on 26 May 2026 |
| Devices already lawfully placed on the market | Art. 120(4) | Further sale allowed; no end date |
The last row matters to distributors. Article 120(4) sets no end date for further sale. The deadlines limit the first placing on the market, not the sale of existing stock.
Which conditions must a legacy device meet?
An MDD certificate only stays valid if a notified body issued it from 25 May 2017, it was still valid on 26 May 2021 and nobody withdrew it. The device and the manufacturer must then also meet five conditions.
Article 120(2), second subparagraph, and Article 120(3c) MDR require that:
- the device continues to comply with Directive 93/42/EEC or 90/385/EEC;
- its design and intended purpose have not changed significantly;
- it presents no unacceptable risk to patients, users or other persons;
- the manufacturer had a quality management system under Article 10(9) by 26 May 2024;
- the manufacturer or its authorised representative applied to a notified body by 26 May 2024 and signed a written agreement with it by 26 September 2024.
Missed the 2024 dates? Then the transition rule offers no protection. Legacy devices also already fall under the MDR rules on post-market surveillance, market surveillance, incident reporting and registration (Article 120(3d)).
Why does a manufacturer outside the EU need an authorised representative?
A manufacturer not established in a Member State can only place a device on the Union market if it designates a sole authorised representative. That representative must have its seat in the Union and accept the mandate in writing.
This follows from Article 11(1) and (2) MDR and the definition in Article 2(32). A company in London, Zurich or Boston cannot take the role itself. The mandate covers at least all devices of the same generic device group. Article 11(3) lists the minimum tasks. The representative checks that the EU declaration of conformity and technical documentation exist and keeps copies. It also handles registration, cooperates with the authorities and passes on complaints. If the manufacturer breaches the MDR, it must end the mandate.
Some duties stay with the manufacturer. Under Article 11(4), the mandate cannot transfer the obligations in Article 10(1) to (4), (6), (7) and (9) to (12), such as risk management and clinical evaluation. The representative needs a person responsible for regulatory compliance permanently at its disposal (Article 15(6)). Location matters too. The competent authority of the representative’s Member State acts as the manufacturer’s authority (Article 11(7)).
When is the authorised representative liable for defective devices?
The authorised representative is liable for defective devices, jointly and severally with the manufacturer, if the manufacturer is established outside the EU and has not complied with its obligations under Article 10 MDR.
That rule is in Article 11(5) MDR. For that reason, a representative will want indemnities, insurance and audit rights addressed in the mandate. Article 10(16) requires manufacturers to have sufficient financial coverage for their liability under Directive 85/374/EEC. The new Product Liability Directive (EU) 2024/2853 does not yet apply: Member States have until 9 December 2026 to transpose it. Read more about product liability under Dutch law.
Is a representative or distributor asking you to sign broad indemnities, or are you the party taking on that risk? Have your MDR mandate with your authorised representative or distributor reviewed before devices reach the Dutch market.
What must importers and distributors check?
Before placing a device on the market, an importer checks the CE marking, the EU declaration of conformity, the authorised representative, the labelling and the UDI. A distributor runs similar checks before selling and may use representative sampling.
An importer is any person established in the Union that places a device from a third country on the Union market (Article 2(33)). A Dutch company buying directly from a US or UK manufacturer is therefore usually the importer.
| Economic operator | Main obligations | Provision |
|---|---|---|
| Manufacturer | Risk management, clinical evaluation, technical documentation, quality management system, EU declaration of conformity and CE marking, UDI, post-market surveillance; documents kept for at least 10 years, 15 for implantable devices | Art. 10 |
| Authorised representative | Only for manufacturers outside the EU: checks declaration and documentation, keeps copies, registers, cooperates with authorities, forwards complaints; liability under Art. 11(5) | Art. 11 |
| Importer | Checks CE marking, declaration, authorised representative, labelling and UDI; adds its name and address; adds its details to the registration; keeps a register of complaints, non-conforming devices and recalls | Art. 13 |
| Distributor | Checks CE marking, declaration, the information under Art. 10(11), the importer’s details and UDI, if necessary by sampling; keeps a register of complaints | Art. 14 |
Importers and distributors forward complaints about suspected incidents to the manufacturer immediately (Article 13(8) and Article 14(5)). Watch out with own-brand sales. A distributor selling a device under its own name generally takes on the manufacturer’s obligations (Article 16(1)(a)). For the marking itself, see our page on CE marking in the Netherlands.
Which language does the Netherlands require for labels and instructions?
Labels and instructions for use must in principle be in Dutch. English is allowed only for devices meant exclusively for healthcare professionals who have an adequate command of English.
Article 10(11) MDR leaves the language to the Member State where the device is made available. The Netherlands set it in Article 1 of the Regeling medische hulpmiddelen (Medical Devices Regulation, in Dutch). Paragraph 1 requires Dutch, also for implant information under Article 18(1) MDR. Paragraph 2 contains the English exception. Under paragraph 3, documents for the authorities, the declaration of conformity and field safety notices may be in Dutch or English.
What must you report after a serious incident?
Manufacturers report every serious incident no later than 15 days after becoming aware of it. For a serious public health threat the limit is 2 days. For death or an unanticipated serious deterioration in health it is 10 days.
These deadlines are in Article 87(3) to (5) MDR. In case of doubt, the manufacturer reports within the deadline anyway (Article 87(7)). Field safety corrective actions are reported in advance as a rule (Article 87(8)). The legal duty to report stays with the manufacturer, also where it works with an authorised representative.
The route is less settled than the duty. Reporting through the database Eudamed only becomes mandatory six months after the Commission announces that the relevant module works (Article 123(3)(d)). Commission Decision (EU) 2025/2371, published on 27 November 2025, covers four modules, but not incident reporting. Until that module follows, the old directive rules on reporting information continue to apply. Reports therefore go through the national system. Separately, Article 10a has applied since 10 January 2025. A manufacturer expecting a supply interruption that could seriously harm patients informs its authority and direct customers at least six months in advance.
Who supervises medical devices in the Netherlands and what fines apply?
Inspectors of the Health and Youth Care Inspectorate (Inspectie Gezondheidszorg en Jeugd, IGJ) supervise compliance with the MDR in the Netherlands. The Minister can impose an order subject to a penalty and an administrative fine.
Article 10 of the Dutch Medical Devices Act assigns supervision to the IGJ. Article 12 allows an order subject to a penalty (last onder dwangsom). Under Article 14(1), the fine can reach the sixth fine category of the Dutch Criminal Code or, if higher, 10% of turnover in the financial year before the decision. Fineable breaches include specified paragraphs of Article 10, Article 11(1) and (3), Articles 13 and 14 and Article 87 MDR. Selling without a representative is therefore fineable in itself. For other consumer products the NVWA acts; see our page on a dispute with the NVWA. Corrective action can also mean a product recall in the Netherlands.
Entering the Dutch market from outside the EU: step by step
A non-EU manufacturer works from product to supply chain: class and certificate first, then the authorised representative, registration, Dutch labelling, contracts with importers and a reporting process that meets the MDR deadlines.
- Determine the class under Annex VIII (Article 51) and the conformity assessment procedure under Article 52.
- For legacy devices, check certificate, application and agreement against Article 120(3c).
- Designate a sole authorised representative in the EU and have it accept the mandate in writing (Article 11(2)).
- Register and obtain a single registration number (SRN) under Article 31.
- Prepare Dutch labels and instructions for use, unless the English exception applies.
- Agree with your Dutch importer who handles complaints, incident reports, recalls and supply interruptions under Article 10a.
- Set up a reporting process that meets the 2, 10 and 15-day deadlines in Article 87.
Example: a Swiss manufacturer of class IIa devices supplies a wholesaler in Rotterdam. Its MDD certificate meets Article 120(3c), so it may place devices on the market until 31 December 2028. The wholesaler imports directly and is therefore the importer under Article 13. Before the first delivery, it checks the Dutch labels and the representative’s details. The supply agreement sets out who tells whom about an incident.
Frequently asked questions about the EU MDR in the Netherlands
Can a UK company act as our EU authorised representative?
No. Article 2(32) MDR requires the authorised representative to be established within the Union, and the United Kingdom is not a Member State. A UK group can designate a subsidiary or another company in an EU Member State. That company must accept the written mandate (Article 11(2)).
Does the authorised representative have to be in the Netherlands?
No. Any Member State will do. The choice does decide which authority deals with you. Article 11(7) MDR points to the authority of the Member State where the representative has its registered place of business. A Dutch representative therefore means Dutch authorities.
May a Dutch distributor still sell legacy devices after 2028?
Yes, if the manufacturer lawfully placed them on the market. Article 120(4) MDR allows further sale of such devices without an end date. The 2027 and 2028 dates only limit the first placing on the market. The distributor’s checks under Article 14 still apply.
Are English instructions for use enough in the Netherlands?
Only for devices used exclusively by healthcare professionals with an adequate command of English. Article 1(2) of the Regeling medische hulpmiddelen contains that exception. All other devices need Dutch labels and instructions, as Article 1(1) requires for the information under Article 10(11) MDR.
What if we sell devices without an authorised representative?
Then the device may not go on the Union market at all (Article 11(1) MDR). In the Netherlands, Article 14 of the Medical Devices Act makes that breach fineable. Your importer must also check for a representative under Article 13(2) and hold back delivery until one exists.
Has the IGJ contacted you or your Dutch importer, or do you want to know where your liability as manufacturer, representative or distributor begins and ends? Discuss your position under the EU MDR with MAAK Advocaten.
