Machinery and electronics · EU market entry

Machinery, electronics and connected products in Europe: CE marking and the importer

Manufacturers of machines, power tools, routers and sensors in the United States, China, Japan, Korea, Taiwan or India can sell in the European Union only with the EU conformity mark (CE marking) and a company established in the EU that answers for the product. The Machinery Regulation, Regulation (EU) 2023/1230, adds new duties from 20 January 2027, and since 11 September 2026 the Cyber Resilience Act has required manufacturers of connected products to report security incidents. Your own Dutch company can be the importer and the authorised representative for all your products.

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Short answer

Connected devices made outside the EU, such as the smart devices from Shenzhen that link to the internet (IoT devices), fall under the Cyber Resilience Act, Regulation (EU) 2024/2847. The manufacturer bears the main duties, an authorised representative in the EU is optional under Article 18, and the importer, the company that places the device on the EU market, has duties of its own. For electronic and radio equipment, Article 4 of Regulation (EU) 2019/1020 also requires an economic operator established in the EU, meaning a company in the EU that answers for the product, such as an importer or an authorised representative. Since 11 September 2026 the manufacturer has had to report actively exploited vulnerabilities and severe incidents through the single reporting platform (Article 14) to the national incident response team (CSIRT) and the EU cybersecurity agency (ENISA), with an early warning within 24 hours, a notification within 72 hours and a final report after that, also for devices already on the market. Your own Dutch company can be the importer.

Machinery, electrical equipment, radio equipment and pressure equipment with CE marking may be sold in the EU only when an economic operator established in the EU answers for them, which can be the manufacturer, an importer or an authorised representative. When all of them are based outside the EU, the law gives that role to the company in the EU that stores, packs and ships the goods (fulfilment service provider) under Regulation 2019/1020, Article 4(2)(d). The importer checks the conformity assessment, the declaration of conformity and the technical file, and puts its own name on the product. From 20 January 2027 Regulation (EU) 2023/1230 on machinery replaces Directive 2006/42/EC, and the full requirements of the Cyber Resilience Act apply from 11 December 2027. We set up the Dutch company that acts as your importer and authorised representative, and work with specialists in CE marking and cybersecurity on the technical files.

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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.

You

Your company

  • Own the product, the design and the technical documentation
  • Do the conformity assessment and sign the declaration of conformity
  • Handle vulnerabilities in your connected products
  • Sign the power of attorney and the representative mandate
We

The Dutch company

  • Set up the Dutch private limited company (BV) with the notary, by power of attorney
  • Registration number at the Dutch Chamber of Commerce (KVK), tax number, VAT number, EORI number, the Article 23 licence
  • Bank account, bookkeeping, VAT returns, annual accounts, corporate tax, payroll for service staff
  • Producer registrations for packaging, batteries and electronics in the Netherlands
  • Single point of contact for the CE partner, the warehouse and the customs agent
Specialist partner from our network

Licences and product rules

  • CE gap check against Regulation (EU) 2023/1230 on machinery and the rules for electrical equipment, electromagnetic compatibility (EMC) and radio equipment
  • Cyber Resilience Act readiness: reporting process, documentation, conformity assessment procedure
  • The authorised representative mandate and the importer checks per shipment
  • Notified body contact where a high-risk machine or radio product needs one
  • Warehousing, installation partners and service logistics in the EU

The steps to the European market

What happens from your first question to the day your first product is on the European market.

  1. You tell us what you make, which EU rules apply to it today, whether it connects to a network and which countries you sell in. You then receive our advice on a suitable structure, together with a proposal.
  2. The notary sets up the Dutch company by power of attorney, with your parent company as shareholder. You receive the KVK number, the tax number, the VAT number and the EORI number, and we prepare the bank application.
  3. Your Dutch company becomes the importer and the authorised representative, while the partner drafts the mandate and checks the technical files.
  4. The CE partner checks each product against Regulation (EU) 2023/1230 on machinery, and each connected product also against the Cyber Resilience Act, and then lists what must change before the deadlines.
  5. The name and address of your Dutch company go on the product, the instructions are written in the languages of your markets, and the producer registrations are in place.
  6. Your stock is in a Dutch warehouse, from where machines are shipped and installed across the EU. Your own company sends the invoices, we do the VAT and the bookkeeping, and you get one monthly overview and one contact person.
20 Jan 2027
Regulation (EU) 2023/1230 on machinery applies to every new machine placed on the EU market
11 Sep 2026
Cyber Resilience Act reporting duty for exploited vulnerabilities and severe incidents
11 Dec 2027
Full requirements of the Cyber Resilience Act, including CE marking for cybersecurity

The roles for CE-marked products

With CE marking the manufacturer declares that the product meets every EU rule that applies to it, such as the machinery rules, the low voltage directive for electrical equipment, the directive on electromagnetic compatibility (EMC), the radio equipment directive for anything with a wireless connection, the pressure equipment directive and the restriction of hazardous substances. For most products the manufacturer does the conformity assessment, the procedure that shows the product meets those rules, itself. Some high-risk machinery and equipment must also be examined by a notified body, an independent testing organisation designated by an EU country.

Many CE-marked products, such as machinery, toys and electrical and radio equipment, need an economic operator established in the EU, a requirement of the market surveillance regulation since 16 July 2021 (Regulation (EU) 2019/1020, Article 4). The importer is the company that brings the product into the EU. It checks that the conformity assessment was done and that the EU declaration of conformity and the technical documentation exist, and it checks the CE marking, the type number and the manufacturer’s name and address on the product, as well as instructions in the language of the country of sale. The importer then puts its own name and address on the product or its packaging. The authorised representative is appointed by the manufacturer under a signed mandate, keeps the declaration and the technical documentation, and answers the authorities. One Dutch company can take both roles.

The new machinery rules from 20 January 2027

Regulation (EU) 2023/1230 on machinery replaces Directive 2006/42/EC from 20 January 2027 with immediate effect, so every machine placed on the market from that date must meet the regulation. It covers machines, partly completed machinery, lifting accessories, safety components and interchangeable equipment. For a manufacturer outside the EU, the regulation allows digital instructions, with a paper copy on request, and sets specific requirements for safety functions controlled by software and for machines whose behaviour changes as they learn. Machines on the high-risk list in Annex I need extra checks, by a notified body for those in Part A, while for Part B machines, such as certain presses and woodworking machines, the manufacturer can assess the machine itself when it applies the harmonised European standards in full (Article 25(3)). The duties of importers and authorised representatives are now written into the regulation itself.

A product that meets the current directive today needs a comparison with the new regulation (gap check) for shipments and for unsold stock after 20 January 2027. The technical file, the risk assessment, the declaration of conformity and the instructions are updated, while the CE mark stays the same. The CE partner does that check, and your Dutch company keeps the updated file as importer.

Want our team to have a look at your situation?

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 Cyber Resilience Act for connected products

The Cyber Resilience Act, Regulation (EU) 2024/2847, applies to every product with digital elements that connects to a device or a network, such as routers, smart home products, industrial controllers, connected machinery, sensors, wearables and the software that comes with them. Medical devices, vehicles and aviation products have their own rules and are excluded. For radio equipment, the cybersecurity requirements of the radio equipment directive have applied since 1 August 2025.

The Act takes effect in two steps. Since 11 September 2026 the manufacturer must report an actively exploited vulnerability or a severe incident, with an early warning within 24 hours and a notification within 72 hours, followed by a final report within 14 days after a fix is available for a vulnerability or within one month for a severe incident. That duty also covers products already on the market. From 11 December 2027 the full requirements apply, namely security built into the product design, a process for handling vulnerabilities, security updates for at least five years, technical documentation and CE marking that includes cybersecurity. Importers check that the manufacturer has done this work, and an authorised representative, if you appoint one, keeps the documentation. A manufacturer of connected products outside the EU that sells in Europe relies on its EU importer for the importer checks and for contact with the authorities.

Why the Netherlands for industrial and electronic products

Containers and air freight enter Europe through Rotterdam and Schiphol. Many machinery and electronics brands from Asia and the United States distribute from logistics parks at Venlo and Tilburg. In the Netherlands the Dutch Authority for Digital Infrastructure (RDI) supervises electronics and radio equipment, the Netherlands Labour Authority supervises machinery used at work, and the Netherlands Food and Consumer Product Safety Authority (NVWA) supervises consumer products.

As importer, your Dutch company holds the EU customs number (EORI) and the Article 23 licence, which lets it report import VAT in its VAT return and avoid paying that VAT at the border, although any customs duty is still due at import. Corporate tax is 19% on the first €200,000 of profit and 25.8% on profit over that amount. Service engineers you bring to the Netherlands may be entitled to the 30% ruling, a tax relief on part of their salary. Importing and distributing through the Netherlands and setting up a subsidiary in Europe cover these subjects in more detail.

Based on Regulation (EU) 2019/1020 (market surveillance), Regulation (EU) 2023/1230 (machinery, as amended by Regulation (EU) 2026/1744), Directives 2014/35/EU, 2014/30/EU and 2014/53/EU, Regulation (EU) 2024/2847 (Cyber Resilience Act) and the guidance of the RDI, as applied in September 2026. The European Commission describes the reporting duties in Cyber Resilience Act reporting obligations and the summary of the Cyber Resilience Act. Specialised partners prepare the technical files, and we coordinate their work.

Common questions

My machines already have CE marking. Do I still need an EU company? +
You still need one, because CE marking is only the manufacturer’s declaration. The EU rules also require a company established in the EU that keeps the documentation and answers the authorities, which can be the importer or an authorised representative. When all of them are outside the EU, the law gives that role to a fulfilment service provider in the EU. Your own Dutch company can take the role and put its name next to yours on the product.
Does a machine sold before 20 January 2027 have to be updated? +
Machines placed on the market before that date stay under the directive, and machines placed on the market from 20 January 2027 fall under the regulation with immediate effect. For stock in the importer’s warehouse, the placing on the market is still to come, according to the European Commission’s guide to EU product rules (Blue Guide, section 2.3), so a machine that is still unsold on 20 January 2027 must meet the regulation. The CE partner checks the dates for your shipments and your stock.
Is my industrial sensor or controller a product with digital elements? +
It is a product with digital elements when it connects to a device or a network, directly or indirectly. Controllers, gateways, sensors with a data connection, the screens through which operators control a machine (HMIs) and their software all fall under the Cyber Resilience Act. The reporting duty has applied since 11 September 2026, also for products already on the market.
Can I appoint an authorised representative in Germany and import through the Netherlands? +
The representative can be in any EU country, including Germany. Most companies combine the representative and the importer in one company, in the country where the stock is, so that the name on the product, the customs declaration and the invoice are the same.
What does the Dutch company cost? +
The setup of the company is a one-time cost. Running the company means bookkeeping with VAT returns, the annual accounts and the corporate tax return, plus payroll if you employ service staff. Your proposal states the whole amount before you decide, and the CE partner quotes per product family.
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