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Declaration of Conformity MDD Class I

This document declares that a medical device conforms to the EU Medical Device Directive. It lists the manufacturer, device name and version, classification as a class I medical device, and that conformity was assessed using Appendix VII of the directive.

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dhir.ankur
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55 views2 pages

Declaration of Conformity MDD Class I

This document declares that a medical device conforms to the EU Medical Device Directive. It lists the manufacturer, device name and version, classification as a class I medical device, and that conformity was assessed using Appendix VII of the directive.

Uploaded by

dhir.ankur
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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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”.

Place, Date, Signature of CEO

Template Copyright openregulatory.com. See template license.


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

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