EU IVDR Declaration Acceptance Criteria

IMPORTANT - This guideline is for information purposes only and does not constitute legal advice. This guide is for communicating compliance with the European Union In-Vitro Diagnostic Medical Device Regulation EU 2017/746 ("EU IVDR"). The acceptance criteria below is for communicating the presence of substances as defined in section 10.3 of the regulation.

  1. On company letterhead.
    • Needs to indicate that the declaration/certificate is an official company release. 

  2. Includes the proper EU In Vitro Diagnostic Medical Device Regulation (IVDR) legislative reference. This indicates the supplier has some awareness of the legislation being inquired about. Actual legislation title: Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices. Other acceptable references include:
    • EU IVDR 2017/746.
    • EU In-Vitro Diagnostics Regulation.
    • In-Vitro Diagnostics Regulation 2017/746/EU.

  3. Includes a clear reference to parts or products being covered by the declaration. This can be:
    • Company level or blanket statement without individual part(s)/product(s) listing, e.g. "This declaration applies to all products sold by ABC Corporation," "This statement applies to all products produced by ABC Corporation except as listed below," etc.
      • However, parts/products that are not compliant must still be specifically identified.
    • Part-level declaration listing specific parts individually.

  4. Declares compliance status.
    • States that it does not contain any substances as defined in section 10.3 of the regulation.
    • States that it does contain any substances as defined in section 10.3 of the regulation.

  5. Declares substances present if applicable.
    • If a part or parts contain a substance as defined in section 10.3, the declaration must include which substance(s) are present and be linked directly to the part or parts in which they are present.

  6. Signed by an appropriate individual.
    • Name, contact details and position must be included.
    • Must be an employee of the company issuing the declaration.
    • Position/job title should indicate a degree of familiarity with materials or product adequate to stating compliance status. 
      • e.g. Engineering, Quality, Materials, Compliance Manager.

  7. Date of reference.
    • The substances referenced in section 10.3 refer to regulatory substance lists that are updated regularly. Therefore, the declaration must identify which list is referenced (ideally, the most current list available). This may be done by:

 

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