I have my own company in ***. I buy glasses frames and sunglasses from a factory. The factory just send me a Declaration of Conformity of Optical Frames which says that they meet the MDR 2017/745. What does that mean for me? What do I have to do?
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ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more 
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
If you put on your own name those glasses frames on the market, then those frames are your medical device. It means that you need to have by yourself prepared Technical documentation according to the Annex II and Annex III of the MDR 2017/745. It means also, that you have to implement ISO 13485 in your company no matter that you are not producing anything by yourself.
If you are not putting those glasses frames with your own brand name, then the Declaration of conformity from the factory is almost enough. Besides that, you need to have also a description of the device, intended purpose, and specification.
For more information, please see:
- EU MDR Annex II - Technical documentation https://advisera.com/13485academy/mdr/technical-documentation/
- EU MDR Annex III - Technical documentation on post-market surveillance https://advisera.com/13485academy/mdr/technical-documentation-on-post-market-surveillance/
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Nov 02, 2022