Description:
This Declaration of Conformity template documents our formal statement that the devices listed in Annex I – Device details comply with Regulation (EU) 2017/745 or Regulation (EU) 2017/746.

• Identify the device(s) covered ([Device Name] / EU certificate scope) and control Document Number and Revision.

• Record Manufacturer details including address and SRN.

• Document Authorized Representative details when applicable, including SRN.

• Capture Notified Body details and EU Certificate when applicable.

• State the Conformity Assessment procedure (MDR/IVDR Annex IX/X/XI).

• Declare applicability of other relevant Union legislations (if any).

• Document Common Specifications applicability (or justify none).

• Finalize Approval with place/date and PRRC signature.

Your needs:

• EU declaration of conformity

• EU declaration of conformity for MDR compliance

• Reduce rework, speed up technical documentation reviews, and strengthen audit readiness.

Use this template when issuing or updating the EU DoC for a device family, aligned to the certificate scope and the latest controlled technical documentation.

It captures device and compliance identifiers. SRN is the Single Registration Number and matters for traceability. Basic UDI-DI anchors device family identification and matters for consistent documentation.

• Confirm manufacturer identity and responsibility statement.

• Define applicable regulation (MDR/IVDR) and conformity assessment annex.

• Maintain Notified Body/certificate details where required.

• Document common specifications applicability (or justified absence).

• Provide Annex I device details (Basic UDI-DI, UDI-DI, class/rule, intended purpose).

At Lexqara, we align your DoC with your technical file, certificates, and GSPR evidence so declarations stay consistent across updates and markets. Resource Center [https://lexqara.com/resource-center] and Regulatory Strategy [https://lexqara.com/services/regulatory-strategy]. EU MDR (Regulation (EU) 2017/745) [https://eur-lex.europa.eu/eli/reg/2017/745/oj]. Download the template or request a short gap assessment.