Short answer: yes.Can a (class I) medical device be manufactured in a GMP certified site with no ISO13485 or even in a manufacturing site with a QMS which is not certified by a external body?
1. The actual requirements are the ones listed in the MDR, not compliance with 13485.If you won't apply for ISO 13485 certification you cannot be sure that you meet all the requirements.
so our own QA team cannot certify us as compliant? I didn't see a requierment for external certification.audited by competent, independent people
They can't "certify" you as such, but they might determine that it's compliant, and if they are competent and independent their determination might be valid.so our own QA team cannot certify us as compliant?
There is none.I didn't see a requierment for external certification.
I would want to make available on the market.Out of interest - are you asking as you're wanting to make available on the market or wanting to apply a Health Institution Exemption?
Actually my company is the legal manufacturer and we are looking for a manufacturing site to manufacture our product (Dispersible tablets)Note: You may lose some business with potential partners and tenders if you don't have ISO 13485 certification.