MAAK Advocaten is a specialised law firm in Amsterdam with in-depth expertise in market access, product regulation and CE marking. Our Dutch lawyers guide manufacturers, importers and distributors from the first compliance strategy through to a successful market introduction, in Europe and far beyond. Do you do business with non-European parties? Then have yourself well informed about placing products on the market, or putting machinery into service.
What is market access and which legal obligations apply in the Netherlands and the EU?
Market access (markttoegang) is the right to place products on a particular market, where you must fully meet the applicable product regulation, conformity assessment requirements and labelling duties, which differ per market and product category.
In the European single market this namely comprises a broad range of obligations: completing the correct conformity assessment procedure, drawing up technical documentation, issuing an EU declaration of conformity, applying CE marking and setting up post-market surveillance. Manufacturers, importers and distributors must, however, not only meet today’s rules. More than 60% of businesses in the manufacturing industry anticipate upcoming European product regulation insufficiently, with costly market interruptions as a result.
Our Dutch specialised lawyers in Amsterdam translate complex European and Dutch regulation into concrete compliance strategies that match your sector, your products and your position in the chain. Consequently, our Dutch product law lawyers not only think along reactively, but help you get ahead of the curve early so that your market position stays protected.
What is the CE marking procedure for the European market?
CE marking is a mandatory European conformity mark that demonstrates a product meets all applicable EU legislation on safety, health and the environment, and may therefore be traded freely within the European single market.
CE marking is not applied for at a government authority, but obtained through a conformity assessment (conformiteitsbeoordeling) route that the manufacturer or importer completes itself. The manufacturer draws up technical documentation, performs a risk analysis, tests the product against the applicable EU directives and then draws up an EU declaration of conformity. Depending on the type of product, the involvement of an accredited Notified Body (aangemelde instantie) is mandatory, for example for medical devices, high-risk machinery and certain personal protective equipment. The route usually takes 4 to 16 weeks.
A correct assessment of the applicable directives is the first, and immediately most critical, step. A wrong estimate namely leads to costly re-assessment obligations or delayed market introductions. Our lawyers have in-depth knowledge of a wide range of product categories and work closely with technical experts and test laboratories. Contact us without obligation for legal advice on your CE conformity route.
Which international markets does MAAK Advocaten support with market access from the Netherlands?
International market access advice comprises the legal guidance on product regulation, certification routes and compliance requirements in the target market, both for new product introductions and for retaining an existing market position when regulation changes.
Our lawyers have a strong international network and guide your organisation with access to the European single market via CE marking, the United Kingdom via UKCA certification, the United States via FDA registration and FCC approval, and onwards to Canada, Australia, China, India and South America. For each target market, we coordinate cooperation with local technical experts, test bodies and authorised representatives for a pragmatic and cost-effective approach.
Where regulatory barriers delay or wrongly prevent your market access, we help your organisation challenge these through legal and administrative channels, including regulatory litigation. In addition, we advise on import and customs compliance and the consequences of trade restrictions for your market position.
When does your organisation need an EU Authorised Representative in the Netherlands?
An EU Authorised Representative (EU-vertegenwoordiger) is a party established in the European Union that a non-European manufacturer has authorised in writing to act on its behalf in respect of EU product regulation, and that serves as the point of contact towards the European authorities.
Appointing an EU Authorised Representative is a legal obligation for non-EU manufacturers that want to place products on the European market. Under, among others, the Machinery Regulation (EU) 2023/1230, the Medical Device Regulation (EU) 2017/745 and the AI Act, a designated EU Representative must be available before the product is placed on the market. Non-compliance can, however, lead to sales bans and considerable fines imposed by national market surveillance authorities. Our lawyers advise on the most appropriate structure, the contractual arrangements and the associated allocation of risk. Request a no-obligation advisory meeting.
How does MAAK Advocaten guide your product launch in the Netherlands and beyond?
Legal guidance during a product launch is an integrated service that covers all legal aspects, from the first compliance strategy through to market introduction, including conformity assessment, technical documentation, labelling requirements and post-market surveillance.
Our lawyers in Amsterdam guide suppliers, manufacturers, importers, distributors, online platforms and fulfilment businesses. Each position in the chain, however, brings different legal obligations. European market surveillance research shows that, in sampling, an average of 30 to 40% of the products examined do not fully meet the applicable regulation. Consequently, proactive legal guidance is not a luxury but a strategic investment that prevents costly enforcement actions, forced recalls and liability claims.
Practical example: a Dutch manufacturer of industrial IoT equipment wanted to enter the EU, the United Kingdom and the United States simultaneously. The product fell under the Radio Equipment Directive, the Low Voltage Directive and the Cyber Resilience Act at the same time. MAAK Advocaten coordinated the conformity routes per market and guided the UKCA procedure and the FCC registration through our international network. Ultimately, the manufacturer entered all three markets within the planned time frame. Schedule an introductory meeting to discuss your situation.
Which sectors does MAAK Advocaten serve with market access?
Sector-specific market access advice is essential because the applicable regulation, conformity routes and enforcement risks differ strongly per product category, and a generalist inevitably lacks the knowledge that makes the difference in your specific market.
Our legal experts in the Netherlands advise daily on market access and product regulation for electrical and electronic products, machinery and mechanical engineering, life sciences and medical devices, automotive and mobility, the energy transition, consumer products, chemical substances, and software and AI. In addition, we are at home in the construction, cosmetics, maritime and printing-equipment sectors. That broad sector knowledge, combined with a full focus on the manufacturing industry, makes it possible to advise quickly and precisely, even for complex or cross-border products.
Do you recognise your sector? Our Dutch specialised lawyers in Amsterdam are ready for a free introductory meeting. Schedule an appointment or call directly on +31 (0)20 210 31 38.
Why do organisations choose MAAK Advocaten for market access?
MAAK Advocaten in Amsterdam distinguishes itself through legal depth, sector knowledge and an integrated approach that is rarely found at other law firms. Our specialists focus entirely on the legal challenges of the manufacturing industry. That focus makes the difference.
Our proven track record in complex market access projects gives your organisation the certainty that even challenging and innovative products are in good hands. Through our international network, you have direct access to Notified Bodies, test laboratories and local counsel worldwide. Our six integrated areas of expertise work together seamlessly, so that knowledge of product regulation also carries through into your contracts and proceedings. We namely keep a close eye on European developments and anticipate new regulation, so that you can get ahead of the curve early. You also always have personal contact with an experienced lawyer, no juniors as your first point of contact.
We go beyond legal advice: we understand your business, share experience and deliver results. Contact us today for a no-obligation conversation on +31 (0)20 210 31 38 or by email.
Frequently asked questions about market access and product regulation in the Netherlands
What is the difference between CE marking and UKCA marking?
CE marking gives access to the European single market of 27 member states. UKCA is the British equivalent, mandatory for the British market after Brexit. Both routes have comparable conformity assessment procedures, but are based on separate legislation and require separate documentation. MAAK Advocaten guides both routes and coordinates them efficiently where possible.
What is the role of an importer in product regulation?
An importer that places products from outside the EU on the market carries considerable responsibility. It must namely verify that the manufacturer has completed the conformity procedure, that the required technical documentation is available and that the product is correctly marked and labelled. In the case of non-conforming products, the importer is jointly liable.
When is a product recall mandatory in the Netherlands?
A product recall is mandatory when a product poses a serious risk to consumer safety and the risk cannot be limited in another way. Under the General Product Safety Regulation, there is an active notification duty to the competent authority. MAAK Advocaten guides both voluntary and imposed recalls.
