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January 24, 2021

Template: Declaration of Conformity for MDD Class I Devices

Dr. Oliver Eidel
Meta-Documents

This is a free template, provided by OpenRegulatory.

A preview of the template is shown below. You can download it as Word (.docx), PDF or markdown file.

The template license applies (don't remove the copyright at the bottom).

Download as:
Beginning of template

EC Declaration of Conformity

Manufacturer

<Company Name>

<Company Address>

Medical Device

<Name of Device>

<Version of Device>

<Basic UDI-DI, if applicable>

Classification

Medical Device Class: I

Classification based on appendix IX, section 3, rule 12 of the Directive 93/42/EEC.

Conformity Assessment

Conformity assessment procedure: Appendix VII of the Directive 93/42/EEC.

The Medical Device referenced above meets the provisions of the Directive 93/42/EEC for Medical Devices.

The actual nitty-gritty proof that you’re meeting the provisions is fulfilled by going through the essential requirements of the MDD and documenting that.

This document needs to be signed in some way. If you’re using software which supports electronic signatures, use it to sign this document. Otherwise, print it out, sign it old-school, scan it and upload it to your QMS folder.


Template Copyright openregulatory.com. See template license.

Please don’t remove this notice even if you’ve modified contents of this template.

End of template

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