Recognized/Harmonized Standard Verification Form – ISO 20417
Recognized/Harmonized Standard Verification Form – ISO 20417:2021
What is a Recognized/Harmonized Standard Verification Form – ISO 20417:2021?
This template enables you to demonstrate objective evidence with all relevant requirements for the identification and labels on a medical device or accessory, the packaging, marking of a medical device or accessory, and accompanying information set out in ISO 20417:2021.
It contains cross-reference tables for the MDR general safety and performance requirements (GSPR).
Why do you need it?
This new standard is intended to serve as a uniform basis for existing requirements that are already implemented in a large number of product-specific standards, thus contributing to the harmonization of requirements.
Compared to EN 1041, this new standard specifies considerably more information to be provided by the manufacturer. Many of the new requirements are directly correlated to the requirements of Annex I, Section 23 of the MDR. However, the standard usually gives more details and continues to provide very practical information on the implementation of individual requirements. In addition, topics such as electronic documentation and the handling of information for lay user are also addressed in more detail.
Using this template as verification evidence is an easy and straight forward way to show compliance with the standard.
By using our template as controlled document you can easily fulfill this requirement.
How to use it?
- Buy the template and download it straight away.
- Fill in all tables and reference your evidence documentation, e.g. process validation test reports or instruction for use sections. The instructional text within the templates helps you.
- Sign it, file it in your technical documentation and reference it in your Essential Requirement / GSPR Checklist.
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