Selling medical devices in European countries can be a lucrative opportunity for manufacturers and distributors, especially with rising demand for innovative healthcare solutions. However, navigating the regulatory landscape across Europe requires a strategic approach—particularly in countries like the Netherlands, which follows the EU Medical Device Regulation (EU MDR 2017/745). This guide provides step-by-step instructions to help you sell medical devices in Europe legally and successfully, with a focus on market entry through the Netherlands.
Why Choose the Netherlands for Entering the European Medical Device Market?
The Netherlands is considered a strategic gateway to the European market. With its advanced healthcare infrastructure, well-connected logistics network, and high demand for quality medical devices, the Netherlands is often the first choice for international manufacturers seeking EU market access. Moreover, many international companies choose to set up their EU Authorized Representative (EU AR) or import operations in the Netherlands due to its regulatory clarity and business-friendly environment.
Step 1: Understand the EU MDR Compliance Requirements
The first and most important step is understanding and complying with EU MDR 2017/745, which replaced the Medical Device Directive (MDD). The regulation ensures that all medical devices sold in the EU meet strict safety, performance, and quality standards.
Key requirements include:
- Proper classification of your medical device (Class I, IIa, IIb, III)
- Technical documentation including device description, design verification, clinical evaluation, and risk analysis
- Implementation of a Quality Management System (QMS), ideally ISO 13485 certified
- Post-market surveillance and vigilance systems
Step 2: Classify Your Medical Device
Your device must be classified based on its risk, duration of use, and invasiveness. The four classes are:
- Class I – Low risk (e.g., bandages, reusable surgical instruments)
- Class IIa – Medium risk (e.g., dental fillings, hearing aids)
- Class IIb – Higher risk (e.g., ventilators, infusion pumps)
- Class III – Highest risk (e.g., implantable pacemakers, heart valves)
Your classification determines the level of regulatory scrutiny and the need for a Notified Body assessment.
Step 3: Appoint an EU Authorized Representative (If Located Outside the EU)
If your business is located outside the European Union, you must appoint a qualified EU Authorized Representative (EU AR). This representative acts as your legal liaison with EU regulatory authorities and is responsible for ensuring your compliance with EU MDR.
Why the Netherlands?
The Netherlands is home to several reputable EU AR service providers, and its central location makes it ideal for market access to the entire EU.
Step 4: Prepare Technical Documentation and Clinical Evaluation
Create a comprehensive Technical File that includes:
- General Safety and Performance Requirements (GSPR) checklist
- Device description and specification
- Risk management file
- Clinical evaluation report (CER)
- Post-market surveillance plan
- Instructions for use (IFU) and labeling
For higher-class devices, clinical evaluation plays a vital role. You must either provide clinical investigation data or justify equivalence with a similar, already-approved device.
Step 5: Engage a Notified Body (For Class IIa, IIb, and III Devices)
If your device falls under Class IIa, IIb, or III, you must engage a Notified Body (NB) to assess your conformity with EU MDR. They will review your technical documentation, QMS, and manufacturing processes.
The Netherlands hosts several EU-recognized Notified Bodies, such as DEKRA and BSI Netherlands, known for their efficient assessments.
Step 6: Obtain CE Marking
Once your device complies with EU MDR and passes any required Notified Body assessments, you can affix the CE mark to your product. This mark demonstrates conformity and allows you to freely market your medical device in all 27 EU countries.
The CE mark must be visible on:
- Product labeling
- Packaging
- Instructions for use
It’s your passport to the European market.
Step 7: Register the Device in EUDAMED
After obtaining the CE mark, you must register your device and economic operators (manufacturer, EU AR, importer) in the EUDAMED database. Although EUDAMED is still under phased implementation, registration is mandatory in many cases and highly recommended for transparency and traceability.
Step 8: Select Importers and Distributors in the Netherlands
Once you’re compliant and your product is CE marked, it’s time to enter the market. Partner with local importers and distributors in the Netherlands who understand Dutch healthcare procurement systems and can promote your device effectively.
Make sure your local partners:
- Are trained on your product
- Fulfill EU MDR obligations for importers/distributors
- Assist with market penetration and logistics
Step 9: Monitor Post-Market Performance
Your responsibilities don’t end after the device hits the market. Under EU MDR, manufacturers must implement a robust Post-Market Surveillance (PMS) and Vigilance system. This includes:
- Collecting feedback and adverse event reports
- Conducting periodic safety updates
- Implementing corrective actions if needed
Proactive post-market monitoring builds trust and ensures long-term compliance.
Step 10: Stay Updated with Regulatory Changes
EU MDR is an evolving regulation. Regular audits, updated guidance documents, and new standards may affect your compliance status. Subscribe to EU Commission updates and stay in touch with your Notified Body and EU AR for regulatory intelligence.
Why Choose Operon Strategist?
Operon Strategist is your trusted partner for seamless entry into the European medical device market. We offer end-to-end regulatory support, from EU MDR compliance and CE marking to technical documentation and Notified Body coordination.
What Sets Us Apart:
- Proven Expertise: Over 1000+ successful projects across EU, USA, and other regulated markets
- EU Market Specialists: Deep knowledge of Netherlands-specific and EU-wide regulations
- Complete Solutions: ISO 13485, QMS setup, EU Authorized Representative support
- Fast-Track Entry: We reduce time-to-market with strategic and compliant execution
Ready to Enter the European Market?
Let our regulatory experts simplify your compliance journey and accelerate your sales in the Netherlands and across Europe.
📩 Contact Us Today for a free consultation!