Class 1 non-sterile device, need certified QMS or not?

ChrisM

Quite Involved in Discussions
Reading through the EU Medical Device Regulation 2017/745, for a Company designing and manufacturing a Class 1 device that is non-sterile, non-invasive and non-measuring, it appears that in order to prepare a DoC under Article 52 paragraph 7, we only need to prepare product Technical Files and conduct Post-Market activities, as per Annexes II and III. Is my reading and interpretation of the Regulations correct, that we are not required to have a documented Quality Management System, let alone a certified QMS?
 

shimonv

Trusted Information Resource
Hi Chris,
QMS yes (See attached), certification no. However, some business partners may require ISO certification from you.

Shimon
 

Attachments

  • Guidance Notes for Manufacturers of Class I Medical Devices cover.pdf
    190 KB · Views: 138

ChrisM

Quite Involved in Discussions
Thank you; I was looking through the index of MDCG documents earlier in the week and must have missed this one. As a fairly new (not quite start-up) company with only a couple of dozen staff, the cost and need for a certified QMS are additional financial burdens that we can do without! Certification costs are prohibitively expensive as it is, plus with almost everyone talking to each other on a daily basis, the possibility of failing to do something due to lack of written procedures is minimal - however it does appear that we will have to do something to tackle this requirement. Our customers tend to be individuals or very small businesses, so no requirement from them for ISO9001 or ISO13485
 
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