Declaration of conformity

Technical documentation template

Declaration of conformity for MDR/IVDR technical documentation

Use this editable Declaration of conformity to document conformity with Annex I GSPRs and build a structured technical file for EU regulatory submission.

Map GSPR evidenceDocument compliance with General Safety and Performance Requirements.

Structure the technical fileOrganise device description, design, verification and validation evidence.

Prepare for submissionSupport Annex II/III compilation and notified-body review.

Best for: MDR/IVDR technical documentation, GSPR checklists, regulatory strategy and submission packages.
Includes: editable sections for device description, GSPR tables, evidence references and declarations.
Format: editable template available through the standard WooCommerce download flow.

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Lexqara helps manufacturers compile technical documentation that meets MDR 2017/745 and IVDR 2017/746 expectations. Explore the Resource Center or review our Technical Documentation & Regulatory Submission Support.

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.

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Template preview: Declaration of conformity

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Declaration of Conformity

For

[Device Name]

/OR Devices under EU Certificate XXXX

Manufacturer Name: [Manufacturer name]

Document Number: XXXX

Revision: XXXX

Manufacturer details

Manufacturer name:	[Manufacturer name]
Address:
SRN:

Authorized representative details

Non-applicable for manufacturer located in EU.

Authorized representative name:
Address:
SRN:

Notified bodies details

Non-applicable for Class I under MDR or Class A under IVDR self-certified devices

Notified body name:
Notified body identification number:
EU Certificate:
Conformity Assessment procedure:	(EU) 2017/745, Annex: XXX or (EU) 2017/746, Annex: XXX Indicate the conformity assessment procedure of the MDR/IVDR EU certificate e.g., Annex IX/X/XI.

Device details

Device trade name(s):

[Device name]

Further information is in Annex I – Device details.

Declaration

[Manufacturer name] declares:

the EU declaration of conformity is issued under the sole responsibility of [Manufacturer name].
the devices described in Annex I that are covered by the present declaration is in conformity with (EU) 2017/745 or (EU) 2017/746
To be removed if not applicable the devices described in Annex I that are covered by the present declaration is in conformity with the following other relevant Union legislations requiring an EU declaration of conformity:
- XXX

References

No common specifications are applicable to [device name].

/or

The following table describes the common specifications applicable to [device name].

Common specifications:	XXX
	XXX

Approval

Place of issue of the self-declaration: Address, Country

Date: DD Month YYYY

Approver name: John Doe

Function: PRRC

Signature:

Annex I – Device details

Basic UDI-DI	Device trade names	UDI-DI	Risk class and rule per Annex VIII	Intended purpose	Picture

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Free

SKU LEX-FORM-EU-018 rev.1 Category Regulatory documents

Declaration of conformity