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# 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".

<br/>

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Place, Date, Signature of CEO
