Swiss companies and the EU: your own Dutch BV as EU entity
Switzerland and the EU signed their new package of agreements, Bilaterals III, on 2 March 2026, but the Swiss parliament and voters still have to approve it, and until it takes effect today’s rules apply. Under those rules a Swiss maker of medical devices counts as a manufacturer from outside the EU (a third-country manufacturer) and needs an authorised representative established in the EU, a Swiss crypto firm can serve EU clients only through a licensed EU company, and every Swiss shipment to an EU customer is an import. A Dutch private limited company (BV) of your own can fill each of these roles as a single EU company.
Ask about your situationSwiss President Parmelin and Commission President von der Leyen signed the Bilaterals III package in Brussels on 2 March 2026. The Swiss government (Federal Council) sent it to parliament on 13 March 2026 and favours an optional referendum, while a committee of the Swiss upper house (Council of States) wants a mandatory one, and the date of the decision is still to be set. Among many other things, the package updates the agreement under which the EU and Switzerland accept each other’s product approvals (the mutual recognition agreement), whose medical device chapter has been out of use since 26 May 2021 and stays so until the package takes effect. The EU therefore treats a Swiss manufacturer like any other manufacturer from outside the EU, and that manufacturer must have an authorised representative established in the EU.
For crypto services, the EU Markets in Crypto-Assets Regulation (MiCA) requires a licensed company with its registered office in an EU country where it provides at least part of its services, its day-to-day management in the EU and at least one director living in the EU, so a Swiss limited company (AG) can obtain a licence only through such an EU company. In the Netherlands the licence comes from the financial markets regulator (Autoriteit Financiële Markten, AFM). A Dutch holding also gives a Swiss group the Dutch exemption for dividends from subsidiaries (participation exemption) and the treaty rate of 0% on dividends from a 10% participation. Your Dutch company (BV) costs from €2,950 excl. VAT, and a holding with an operating company from €4,950 excl. VAT.
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 your Dutch company, and you have one contact person for all of it. Regulatory and licensing partners are chosen per assignment, and you see each price first.
Your company
- Your Swiss company, your products and your EU clients
- The decision on the role of the Dutch company, as representative, licensed company, importer or holding
- Your Swiss tax position, with your Swiss adviser
The Dutch company
- Your Dutch company or holding, set up by power of attorney with the notary
- VAT number, customs number (EORI), the Article 23 application and the payroll registration
- Bookkeeping, VAT returns, payroll, corporate tax returns and annual accounts
- The company file that the regulator or the EU-appointed certification body (notified body) asks for
Regulatory, licence, customs
- Regulatory consultant for the authorised representative duties and the registration in the EU medical device database (EUDAMED)
- Law firm for the MiCA or payment licence file
- Customs broker for the import declarations and the origin claim
Step by step
From a Swiss company with EU clients to a Dutch company in the role your group needs.
- Your plan. You share what you sell in the EU, which licences or product rules apply and which staff you need here. Our team replies with the role of the Dutch company and a quote.
- Your Dutch company. The notary sets up the BV or the holding by power of attorney once all documents are complete.
- The numbers. VAT number, EORI, Article 23 and the payroll registration.
- The role. Label and documentation for the authorised representative, or the licence file with the law firm, or the first import with the customs broker.
- The group. The holding above the EU subsidiaries, dividends under the treaty and the participation exemption, and the yearly review of the structure.
Need, rule, and what your Dutch BV does
| Your need | The rule | What your Dutch BV does |
|---|---|---|
| Sell medical devices in the EU | The medical device chapter of the EU-Swiss mutual recognition agreement stopped on 26 May 2021. The EU treats a Swiss manufacturer like any other third-country manufacturer, so it needs an authorised representative established in the EU, named on the label, an EU importer, and registration in the EU medical device database (EUDAMED). The updated agreement is part of Bilaterals III and applies once that package is in force. | Your own EU authorised representative and EU importer, with its name on the label and the technical documentation at hand for the authorities. Partners with regulatory staff do the vigilance work. See medical devices in Europe. |
| Serve EU clients with crypto services | MiCA, article 59: only a licensed crypto-asset service provider may serve the EU. It needs a registered office in an EU country where it provides at least part of its services, its day-to-day management in the EU and at least one director resident in the EU. The licence gives access to all EU countries. A licence is required since 30 December 2024. | The licensed EU company, with its registered office in the Netherlands, Dutch directors or a Swiss director who relocates, staff on Dutch payroll, bookkeeping and capital. The AFM issues the licence, and a specialist law firm prepares the file. See MiCA licence in the Netherlands. |
| Ship goods to EU customers | Switzerland is outside the EU customs union. Each shipment is an import with a customs declaration, proof of origin for the 0% rate under the free trade agreement, and import VAT. Product rules such as the General Product Safety Regulation (GPSR) ask for a responsible economic operator in the EU. | Importer with its own customs number (EORI) and the Article 23 licence, so the import VAT goes into its VAT return. Responsible economic operator with its name and address on the product. EU seller with Dutch invoices and the one stop shop (OSS) for consumers. See EU representative requirements. |
| Own EU subsidiaries | Treaty Netherlands-Switzerland: Swiss withholding tax on dividends to a Dutch company that owns at least 10% of the capital directly is 0%; 15% in other cases. Under the Dutch participation exemption, dividends and gains from subsidiaries that meet its conditions are free of Dutch corporate tax. The EU directives apply to the Dutch holding as an EU company. | Holding above your EU subsidiaries, with the participation exemption and the EU parent-subsidiary directive for dividends from EU countries. Managed from the Netherlands, so the decisions are taken here. See the Dutch holding structure. |
| Employ people in the Netherlands | An employer with staff in the Netherlands withholds Dutch wage tax and social contributions. A foreign employer can register for payroll only. When the activity grows, the company gets a taxable branch in the Netherlands (permanent establishment). | Employer of your EU sales, service and compliance staff, with Dutch payroll and, where the conditions are met, the 27% expat scheme from 2027 for staff recruited from abroad. See payroll in the Netherlands. |
Bilaterals III is signed, and the Swiss decision is still to come
The package "Stabilisation and further development of Switzerland-EU relations" was negotiated from March 2024 to December 2024 and signed on 2 March 2026. It covers electricity, food safety, health, the free movement of persons, institutional protocols for the single market agreements, EU programmes, road, rail and air transport, agriculture, mutual recognition, space, and a regular Swiss contribution. The Federal Council adopted its message to parliament (the dispatch) on 13 March 2026.
The Federal Council favours an optional referendum, a position it took on 30 April 2025 and repeated on 12 August 2026, while a committee of the Council of States has filed a parliamentary initiative for a mandatory referendum through a transitional provision in the constitution. Until the Swiss parliament and voters have decided and the package is in force, transitional rules apply. You can therefore plan on the 2021 situation for medical devices and the customs border remaining in place through 2027, and your EU company keeps its role as importer, employer and holding once the package takes effect.
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 Swiss medical device manufacturer needs its own EU representative
The trade-facilitating effect of the mutual recognition agreement for medical devices ended on 26 May 2021, as the European Commission stated that day, and since then Swiss manufacturers have been treated like any other manufacturer from outside the EU. For devices sold in the EU they must designate an authorised representative established in the EU, while the EU importer takes on duties of its own. Swissmedic confirmed on the same day that Swiss manufacturers are already required to appoint an authorised representative in the EU.
The representative bears legal duties and legal liability. It verifies the declaration of conformity and the technical documentation, keeps them available for the authorities and cooperates in the follow-up of incidents (vigilance). Many Swiss makers hire a service firm for that role, although your own Dutch BV can also act as authorised representative and importer, with your own staff or a regulatory partner on the file. The role then remains within your group, and once the updated agreement is in force the same company continues as EU importer and distributor.
The MiCA licence requires an EU company
MiCA has applied in full since 30 December 2024. Article 59 limits crypto-asset services in the EU to licensed providers, and a provider must be a legal person with its registered office in an EU country where it provides at least part of its services, its day-to-day management in the EU and at least one director who lives in the EU. A Swiss AG therefore obtains the licence through an EU subsidiary, which can then serve clients in all EU countries, from the Netherlands or through a branch.
The Netherlands is one of the countries where Swiss firms apply. The AFM issues the licence and the Dutch central bank (De Nederlandsche Bank) assesses the financial soundness of the company. The Dutch BV is set up first, with capital, directors and staff on payroll, after which a specialist law firm prepares the licence file and the company submits the application. See the MiCA licence in the Netherlands and a Dutch entity for payments.
The Dutch holding for a Swiss group
Under the tax treaty between the Netherlands and Switzerland, in force in its current text since 30 November 2020, Swiss withholding tax on dividends to a Dutch company that owns at least 10% of the capital directly is 0%, as it is for pension funds, and at most 15% in other cases. The Dutch holding receives dividends and capital gains from subsidiaries that meet the conditions free of Dutch corporate tax under the participation exemption, and as an EU company it uses the EU parent-subsidiary directive for dividends from its EU subsidiaries.
The holding is Dutch for tax purposes provided it is managed from the Netherlands, which means the board meetings, the decisions and the bookkeeping take place here. Dutch corporate tax on its own profit is 19% up to €200,000 and 25.8% above that (2026). See Netherlands versus Switzerland for how the two countries compare as a base, with the Swiss withholding tax and the cantonal rates.
One Dutch company, many roles
The same Dutch company can be the EU authorised representative and importer for your medical devices and other regulated products, with its name on the label, or the licensed EU company for crypto services under MiCA or for payments under the EU payment rules. It can import at EU customs with its own EORI number and the Article 23 licence and sell within the EU through the one stop shop (OSS), own your EU subsidiaries as a holding company with the participation exemption and the treaty rate of 0% on dividends from Switzerland at a 10% participation, and employ your EU staff on Dutch payroll, with the 27% expat scheme from 2027 where the conditions are met.
The company, the address and the directors are yours, and Holdwise sets up and manages the company while the ownership remains entirely with you. Your Dutch company (BV) costs from €2,950 excl. VAT, and a holding with an operating company from €4,950 excl. VAT. Regulatory, licensing and customs work by partners has its own price, which you see first.
Sources
- Swiss Federal Council, press release on the signing of the Switzerland-EU package (25 February 2026), on the signing in Brussels on 2 March 2026.
- Federal Department of Foreign Affairs, dispatch on the Switzerland-EU package, adopted and sent to parliament on 13 March 2026, with the contents of the package.
- Swiss Federal Council, position on the parliamentary initiative for a constitutional amendment (12 August 2026), with the optional referendum favoured.
- European Commission, notice to stakeholders on the EU-Switzerland mutual recognition agreement for medical devices (26 May 2021).
- Swissmedic, new regulations for medical devices as of 26 May 2021.
- Regulation (EU) 2023/1114 (MiCA), article 59, in the ESMA interactive single rulebook.
- Netherlands Authority for the Financial Markets (AFM), licence required for crypto services from 30 December 2024.
- Tax treaty Netherlands-Switzerland, wetten.overheid.nl (in force in this text from 30 November 2020), article 10, paragraphs 2 and 3.
- Dutch Tax Administration, corporate tax rates (2026), participation exemption and Article 23.
- Business.gov.nl, 30% ruling down to 27%, law passed, 1 January 2027.
Last reviewed: 27 October 2026. Based on the official pages named under Sources, as they read on that date. The Swiss parliamentary process for Bilaterals III continues, and the facts on that process are as of 12 August 2026.
What we arrange beyond the company
Once your Dutch company is set up, we can help you with more. When you win a Dutch defence order, the government asks you to place part of the work with Dutch companies, and we find those companies for you. We prepare subsidy applications for your company, such as the Dutch subsidy for renewable energy and climate projects (SDE++) and the tax credit for research and development (WBSO). We help you buy a Dutch contractor or supplier, and we arrange export credit insurance and project finance with the banks.
We agree every fee with you first and link it to the result. For a project that deserves it, we join as co-founder and take a share of 5 to 10% in the project company.
Common questions
Want our team to have a look?
Tell us what your Swiss company sells in the EU, which product rules or licences apply and whether you need staff in the Netherlands, and our team replies with the role of the Dutch company and the steps.
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