Templates General Documents

Updated September 29, 2022

Template: Declaration of Conformity for MDD Class I Devices

Dr. Oliver Eidel

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Related Documents

The following templates are Documents or SOPs related to this template. That means that they mention this template somewhere and (most likely) contain instructions on how and when to fill it out.

Template preview

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.

Expiration Date: 27.05.2024

This date only applies to MDD legacy devices under MDR. For MDR class I devices, this can be left out or filled out “undated”.



Place, Date, Signature of CEO


Template Copyright openregulatory.com. See template license.

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