Regulatory Open Forum

Hi,

is anyone aware of a guidance on assistive technology applicable under the EU MDR, which would be similar to the brilliant Assistive technology: definitions, examples and safe use published (and just recently updated) by MHRA in the UK? https://www.gov.uk/government/publications/assistive-technology-definition-and-safe-use

I'm a bit hesitant to use the MHRA document as my go-to guidebook after Brexit.

Has anyone applied the MHRA guidance outside the UK and got away with it? :)

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Tiina Tyni
Regulatory Consultant
Finland
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