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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.

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