The European Union Medical Device Regulation (EU MDR) has significantly reshaped the regulatory landscape for medical device manufacturers across the EU, including the Netherlands. Whether you’re a startup introducing your first product or an established manufacturer updating your portfolio, understanding and complying with the EU MDR is critical for accessing and staying in the European market.
What Is EU MDR?
The EU Medical Device Regulation (Regulation (EU) 2017/745) replaced the Medical Device Directive (MDD) and the Active Implantable Medical Devices Directive (AIMDD) in May 2021. It was introduced to improve the safety, performance, and transparency of medical devices in the EU.
The regulation applies to all medical device manufacturers selling products in the EU, regardless of where the manufacturer is based.
Key EU MDR Requirements for Manufacturers in the Netherlands
1. Product Classification and Scope
Manufacturers must classify their devices according to risk class (Class I, IIa, IIb, or III). Classification determines the level of regulatory control and conformity assessment route.
Tip: Review Annex VIII of the MDR for classification rules.
2. Conformity Assessment & Notified Body Involvement
Depending on the risk class, you may need to work with a Notified Body (NB). These are designated organizations responsible for assessing conformity before CE marking.
- Class I (non-sterile, non-measuring) devices may be self-certified.
- Class IIa, IIb, and III devices require NB involvement for certification.
3. CE Marking and Declaration of Conformity
A CE mark is mandatory to market medical devices in the EU. It proves that the device complies with all relevant EU MDR requirements. A Declaration of Conformity (DoC) must also be created and kept on file.
4. Technical Documentation
Annex II and III of EU MDR specify the required technical documentation, which includes:
- Device description and specifications
- Design and manufacturing information
- Risk management file
- Clinical evaluation report
- Post-market surveillance plan
Documentation must be clear, structured, and regularly updated.
5. Quality Management System (QMS)
A certified QMS (like ISO 13485:2016) aligned with EU MDR requirements is mandatory for manufacturers of Class IIa and above devices.
Your QMS should cover:
- Design controls
- Supply chain oversight
- Complaint handling
- CAPA processes
- Internal audits
6. Clinical Evaluation and Investigation
Manufacturers must demonstrate clinical safety and performance through:
- Clinical evaluation reports (CERs)
- Post-market clinical follow-up (PMCF)
- In some cases, clinical investigations
This requirement applies even to legacy devices previously approved under the MDD.
7. UDI and EUDAMED Registration
All medical devices must carry a Unique Device Identifier (UDI) to improve traceability. Additionally, devices must be registered in EUDAMED, the European database on medical devices.
For Dutch manufacturers, EUDAMED registration also helps maintain transparency and allows easier market surveillance by the authorities.
8. Post-Market Surveillance and Vigilance
Manufacturers must implement a Post-Market Surveillance (PMS) system. This includes:
- Continuous product monitoring
- Periodic Safety Update Reports (PSUR) for Class IIa and above
- Trend reporting and incident reporting
In the Netherlands, the Health and Youth Care Inspectorate (IGJ) closely monitors compliance with these requirements.
9. Labeling and Instructions for Use (IFU)
Labels and IFUs must meet EU MDR Article 10(11) standards, including:
- Clear identification of the manufacturer
- UDI
- Safety warnings and symbols
- Language requirements (Dutch for the Netherlands)
Why EU MDR Compliance Matters for Manufacturers in the Netherlands
- Legal Market Access: No CE mark, no sales in the EU.
- Reputation and Trust: MDR compliance boosts credibility with distributors and end users.
- Avoiding Penalties: Non-compliance can result in recalls, fines, or market bans by IGJ.
- Global Competitiveness: EU MDR sets a high benchmark that strengthens your market position internationally.
How We Help Medical Device Manufacturers in the Netherlands
At Operon Strategist, we offer end-to-end EU MDR consulting services, including:
- Gap analysis of your current compliance status
- Technical documentation preparation
- QMS implementation aligned with MDR and ISO 13485
- Clinical evaluation and PMS strategy development
- EUDAMED registration and UDI support
- Notified Body coordination and audit readiness
Contact Operon Strategist today for a free consultation and discover how we help medical device manufacturers in the Netherlands succeed under the EU MDR framework.