EC Declaration of Conformity
<Name of Device>
<Version of Device>
<Basic UDI-DI, if applicable>
Medical Device Class: I
Classification based on appendix IX, section 3, rule 12 of the Directive 93/42/EEC.
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.
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Please don’t remove this notice even if you’ve modified contents of this template.