EUCEREP B.V.

EUCEREP helps non-EU medical device manufacturers legally sell devices in the EU and UK markets by acting as their regulatory representative, reviewing technical compliance, managing registrations, and ensuring ongoing regulatory compliance.

EUCEREP B.V. Services

1. Regulatory Representation

• Act as EU Authorised Representative (AR) and UK Responsible Person (RP) for medical device manufacturers
• Manage mandate contracts and legal compliance documentation

2. Technical Documentation Review

• Verify Declaration of Conformity (DoC)
• Review technical files, risk management, and post-market surveillance plans
• Confirm device classification and compliance route

3. Device Registration

• Register devices in EUDAMED (EU) and MHRA (UK) systems
• Manage UDI/basic UDI-DI codes
• Track Supplier Registration Numbers (SRN)

4. Labelling Verification

• Review device labels, instructions for use, and packaging
• Ensure AR/UKRP contact details are correct and compliant
• Verify labeling for EU, GB, and Northern Ireland markets

5. Post-Market Surveillance

• Monitor device safety and report adverse events to authorities
• Track regulatory updates and changes
• Manage vigilance reporting timelines

6. Outsourced Testing Oversight

• Manage sterilization validation, biocompatibility testing, and microbiological testing through qualified suppliers
• Ensure all testing meets ISO standards

7. File & Records Management

• Maintain Medical Device File (MDF) for each client
• Store technical documents and compliance records for 5–10 years per regulation

8. Customer Support

• Provide regulatory guidance and compliance updates to clients
• Assist with regulatory change assessments and device updates