Importer Service

An importer is a natural or legal person in the EU who receives a medical device from outside the EU and sells or supplies it in the EU for the first time. “Placing on the market” means making the device available in the EU.

Why You Need?

An EU importer is required to ensure EU regulatory compliance, manage customs and documentation, and assume legal responsibility for placing products on the EU market.

What NEDYS Do？

Ensure EU regulatory compliance
Handle customs clearance and documentation
Assume legal liability for EU market placement
Manage product storage and logistics
Facilitate post-market surveillance for medical devices
Liaise with EU regulatory authorities

Why Choose NEDYS?

Local EU Importer of Record: We act as your official, fully compliant EU Importer based in the Netherlands, enabling legal market access for your products.

Full EU Regulatory Compliance: We ensure full adherence to EU market regulations, including product compliance, traceability, and post-market surveillance requirements.

Reliable and Long-Term Partnership: We provide stable, professional importer service to support your ongoing EU market operations and business expansion.

Risk Mitigation and Legal Security: We reduce your legal and regulatory risks by partnering with a fully qualified, local EU importer.