Designated Representative Form - Netherlands

Designated Representative Form for the Netherlands

Designated Representative Form Template for Netherlands

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What is a Designated Representative Form?

The Designated Representative Form is a crucial document required for non-EU manufacturers seeking to place medical devices on the European market under EU MDR 2017/745. This legally binding agreement, governed by Dutch law, formally establishes the relationship between a non-EU manufacturer and their authorized representative in the Netherlands. The document specifies the representative's obligations to maintain technical documentation, ensure regulatory compliance, and act as the primary contact point with EU authorities. It includes detailed provisions for liability, regulatory responsibilities, and communication protocols, while ensuring compliance with both EU-wide regulations and specific Dutch legal requirements. The form is essential for manufacturers without a physical presence in the EU and must be in place before placing medical devices on the EU market.

What sections should be included in a Designated Representative Form?

1. Parties: Identification of the manufacturer (represented party) and the designated representative, including full legal names, registration numbers, and addresses

2. Background: Context of the appointment, including reference to EU MDR 2017/745 and the requirement for non-EU manufacturers to appoint an EU representative

3. Definitions: Key terms used in the agreement, including regulatory-specific terminology from EU MDR

4. Appointment and Scope: Formal appointment of the representative and specification of products covered by the representation

5. Term and Termination: Duration of the representation and conditions for termination

6. Representative's Obligations: Detailed listing of all duties and responsibilities of the designated representative under EU MDR

7. Manufacturer's Obligations: Responsibilities of the manufacturer to enable the representative to fulfill their role

8. Liability and Indemnification: Distribution of liability between parties and indemnification provisions

9. Confidentiality: Obligations regarding confidential information handling

10. Governing Law and Jurisdiction: Specification of Dutch law as governing law and jurisdiction for disputes

What sections are optional to include in a Designated Representative Form?

1. Insurance: Details of required insurance coverage, optional if covered in separate documentation

2. Sub-delegation: Terms for any permitted sub-delegation of representative duties, needed only if sub-delegation is allowed

3. Quality System Requirements: Specific quality system obligations, optional if covered in separate quality agreements

4. Financial Provisions: Payment terms and financial arrangements, optional if covered in separate commercial agreement

5. Data Protection: GDPR compliance provisions, optional if covered in separate data processing agreement

What schedules should be included in a Designated Representative Form?

1. Schedule 1 - Product List: Detailed list of medical devices covered by the representation agreement

2. Schedule 2 - Technical Documentation: List of technical documentation to be maintained by the representative

3. Schedule 3 - Contact Details: Key contacts and escalation procedures for both parties

4. Appendix A - Power of Attorney: Formal power of attorney document in Dutch legal format

5. Appendix B - Documentation Requirements: Specific requirements for maintaining and updating product documentation

Authors

Alex Denne

Head of Growth (Open Source Law) @ ��Ƶ | 3 x UCL-Certified in Contract Law & Drafting | 4+ Years Managing 1M+ Legal Documents | Serial Founder & Legal AI Author

Relevant legal definitions

Clauses

Relevant Industries

Medical Devices

Healthcare

Pharmaceutical

Biotechnology

Healthcare Technology

Medical Equipment Manufacturing

In-Vitro Diagnostics

Digital Health

Medical Software

Relevant Teams

Regulatory Affairs

Quality Assurance

Legal

Compliance

Product Development

Documentation

International Business Development

Technical Operations

Medical Affairs

Risk Management

Relevant Roles

Regulatory Affairs Manager

Quality Assurance Director

Legal Counsel

Compliance Officer

Medical Device Safety Officer

Technical Documentation Specialist

Regulatory Compliance Manager

Quality Management System Manager

Medical Device Registration Specialist

Head of Regulatory Affairs

Chief Quality Officer

European Business Development Manager

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What is a Designated Representative Form?

What sections should be included in a Designated Representative Form?

What sections are optional to include in a Designated Representative Form?

What schedules should be included in a Designated Representative Form?

Authors

Alex Denne

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