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Can a (class I) medical device be manufactured in a GMP certified site with no ISO13485?

#1
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?
 
#3
If your device is indeed a class I device with not need for conformity assessment, then it is up to you to comply with the applicable regulation through self-declaration. If you won't apply for ISO 13485 certification you cannot be sure that you meet all the requirements.
Note: You may lose some business with potential partners and tenders if you don't have ISO 13485 certification.
 

Ronen E

Problem Solver
Staff member
Super Moderator
#4
If you won't apply for ISO 13485 certification you cannot be sure that you meet all the requirements.
1. The actual requirements are the ones listed in the MDR, not compliance with 13485.
2. I disagree that you can't be sure that you comply unless you are certified. If the system is audited by competent, independent people (from whatever org), and their conclusion is that it complies - that's as close as anyone can get to "being sure".
 
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twanmul

Involved In Discussions
#7
What has been said above by Ronen is valid. There is very little within EU GMP regarding product design & development or how this translates through to risk analysis and the rest of product realisation. I would suggest a gap analysis between the ISO 13485:2016 standard and your current quality management system to hep you identify where areas of potential weakness could be.
Out of interest - are you asking as you're wanting to make available on the market or wanting to apply a Health Institution Exemption?
 
#9
Note: You may lose some business with potential partners and tenders if you don't have ISO 13485 certification.
Actually my company is the legal manufacturer and we are looking for a manufacturing site to manufacture our product (Dispersible tablets)
 

twanmul

Involved In Discussions
#10
Then it is even more important that you assess the standard in terms of section 8 of the standard also - measurement, analysis and improvement. This should tie in with any Vigilance and PMS procedures you've produced.
 
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