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EU Custom-made Device Statement

Meeting Minimum Requirements: Crafting a Comprehensive Manufacturer's Statement for Medical Devices under MDR Guidelines

Manufacturers are required to prepare a statement that fulfills the minimum requirements outlined in MDR, Annex XIII, Section 1.

EU Custom made Statement:

  1. Manufacturer's name and address, including all manufacturing sites.

  2. If applicable, the name and address of the authorized representative.

  3. Data enabling the identification of the specific device.

  4. A declaration stating that the device is intended for exclusive use by a specific patient or user, identified by name, acronym, or numerical code.

  5. The name of the authorized person who issued the prescription, in accordance with national law and their professional qualifications, as well as the name of the relevant healthcare institution if applicable.

  6. Detailed description of the product's specific characteristics as indicated in the prescription.

  7. A statement affirming that the device complies with the general safety and performance requirements stated in Annex I. If any specific requirements have not been fully met, the grounds for non-compliance should be indicated.

  8. When applicable, a notification that the device contains or incorporates a medicinal substance, including human blood or plasma derivatives, tissues or cells of human or animal origin, as referenced in Regulation (EU) No 722/2012.

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EU Custom-made Device Statement
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