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Regarding intended purpose or intended use

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Guest user Created:   Jul 07, 2021 Last commented:   Jul 08, 2021

Regarding intended purpose or intended use

We had a sit down with one of our regulatory consultants and went through our new Manual/IFU ( it’s a combination in one document) and when we came to the chapter about intended use, she proclaimed that since the 26 of may- and MDr is in full place. Its not called Intended use anymore and everywhere it is stated intended use must be replaced with intended purpose instead- is this really the case? Then a lot of the documentation from Advisera that we purchased in December is outdated? Can you confirm or deny this?

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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić Jul 08, 2021

Both terms are used in MDR. The term intended purpose should be inserted in the technical documentation, ie in the product description, instructions for use. Intended use can also be used in clinical evaluation and other documents.

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Jul 07, 2021

Jul 08, 2021