Medical Devices Requirements
If your business manufactures, imports, or distributes medical devices in the Netherlands, you must comply with the requirements set out in the EU Medical Devices Regulation (MDR 2017/745) and the Dutch Medical Devices Decree (Besluit medische hulpmiddelen). These regulations set strict standards for the safety, quality, and performance of medical devices placed on the market.
Manufacturers must obtain CE marking through a notified body before placing devices on the market. Importers and distributors must verify that devices carry proper CE marking and are registered in EUDAMED, the European database for medical devices. The Health and Youth Care Inspectorate (IGJ) supervises compliance in the Netherlands and can order product recalls or impose fines for non-compliant devices.
Requirements
- Conformity assessment: Medical devices must undergo a conformity assessment procedure
- CE marking: Products must bear CE marking before being placed on the market
- Technical documentation: Manufacturers must be able to submit complete technical documentation
- Vigilance: Incidents with medical devices must be reported to the Health and Youth Care Inspectorate (IGJ)
Procedure
- Classification: Determine the risk class of the medical device
- Conformity assessment: Perform the appropriate conformity assessment procedure, possibly with a notified body
- Documentation: Compile the required technical documentation and instructions for use
- Affix CE marking: Affix the CE marking and draw up an EU declaration of conformity
- Registration: Register the device if required
Restrictions
- Market surveillance: The IGJ supervises compliance with regulations and can take measures in case of violations
- Recall obligation: In case of safety issues, manufacturers may be required to recall products
- Liability: Manufacturers are liable for damage caused by defective medical devices