Do we need MDR?
Assign topic to the user
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.
For more information, see:
- EU MDR Article 2 - Definitions https://advisera.com/13485academy/mdr/definitions/
- EU MDR Annex 2 Technical documentation https://advisera.com/13485academy/mdr/technical-documentation/
- EU MDR Annex 3 - Technical documentation for post-market surveillance https://advisera.com/13485academy/mdr/technical-documentation-on-post-market-surveillance/
- EU MDR Annex 8 - Classification rules https://advisera.com/13485academy/mdr/classification-rules/
Comment as guest or Sign in
Nov 23, 2021