Declaration of Conformity Template Medical Devices

This template contains the content of the Declaration of Conformity (DoC) for Medical Devices according to Directive 93/42/EEC.

The template contains the content of the Declaration of Conformity (DoC) for Medical Devices according to Directive 93/42/EEC.

For devices that also need to comply with other directives, these should all be indicated on the Declaration. For questions, please contact us at info@instrktiv.com.

See also our template that complies with the (EU)2017/745 Medical Devices Regulation.

Declaration of Conformity Template Medical Devices

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Frequently Asked Questions

The template is an MS Word file. To open our files you need Microsoft Word.
Yes! All our packages have a 14-day no-reason-required guarantee. So if there is any reason that you are not satisfied, just let us know and we’ll refund your money. As we think that our product really helps you to create better documentation, we don’t think it’ll come to that. But as soon as you have any doubts whether our product is the right fit for you, just put your mind at ease. We will help you to get the results you want, or we will give you your money back!
You can find the following important information on our website:
  • General business terms and conditions
  • Revocation statement
  • User manual template disclaimer
  • Website privacy policy
No! The User Manual Template is a tool that will HELP you to create compliant manuals. We will tell you what elements should be in the manual, how to comply with directives and standards and even provide you with ready-to-use legal texts, but in the end you are responsible for full compliance. There are hundreds of thousands of different products out there and they all come with different risks. So it is impossible to create a template that includes all warnings for all products for example. However, we do tell you HOW you should include your specific product information in order to achieve compliance. Besides that we have included many elements for the main product groups and requirements from standards like the ANSI Z535.6 and IEC/IEEE 82079-1:2019.
As soon as your payment has been completed, you will receive an email with a link to the download page. If you haven’t received an email after some time, please check your spam folder and junk mail. It might be in there! If you haven’t white listed us yet, please make sure you do so if you want to receive our updates on legislation changes, sample instruction manuals and other relevant stuff.
Legislation is subject to improvement and technological progress. That’s why safety standards and/or directives are being updated every now and then. Once part of our community, we send you updates on relevant changes.

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