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Do we need MDR?

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Guest user Created:   Nov 23, 2021 Last commented:   Nov 23, 2021

Do we need MDR?

We are a small Bee spoke company who manufacture Seating/backrests for Wheelchairs we buy in.  I am trying to find out what our requirements are for MDR. if any?
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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.

Expert
Kristina Zvonar Brkić Nov 23, 2021

Considering the definitions of what is a medical device (Article 2 Definitions), to my opinion this is not a medical device. For some device to be medical device, it has to have some of the following purposes: diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease.If I understand correctly your device, helps patients to feel more comfortable in the wheelchair, but it does not contribute to the healing of their health state.  

If you look at your product from the point of view that your seating and brackets prevent developing pressure ulcers or similar skin changes, then it can be considered that seating and brackets are medical products. In that case, they are a class I medical device according to Rule 1 (Annex 8 Classification rules). In that case, it is necessary to implement the ISO 13485 Quality System and prepare the Technical Documentation in accordance with Annex 2 Technical documentation and Annex 3 Technical documentation for post-market surveillance.

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Nov 23, 2021

Nov 23, 2021