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EU MDR Quality System Requirements - Applicable to Class I?

blah01

Involved In Discussions
#1
Our AR tells us that the QS requirements from the EU MDR apply to Class I devices. However I don't think it does based on the following:
Article 10 states: "Manufacturers of devices shall establish, document, implement, maintain, keep up to date and continually improve a quality management system that shall ensure compliance with this Regulation in the most effective manner and in a manner that is proportionate to the risk class and the type of device."

Article 52 section 7 says: "Manufacturers of Class I devices shall declare the conformity of their products by issuing the EU declaration of conformity referred to in Article 19 after drawing up the technical documentation set out in Annexes II and III. If those devices are placed on the market in sterile condition, have a measuring function or are reusable surgical instruments, the manufacturer shall apply the procedures set out in Chapters I and III of Annex IX".

So, Article 10 says that the QMS shall be proportionate to the class of the device, and Article 52 indicates that Annex IX chapters I and III only apply in certain conditions.

Therefore, if you have a Class I device which is not placed on the market in sterile condition, does not have a measuring function or is not a reusable surgical instrument, then the QMS requirements of Annex IX do not apply...or am I missing something?

Feedback would be appreciated.
 

blah01

Involved In Discussions
#4
One more question on this if you don't mind. Being a Class I device, is a self-declaration that we meet the requirements of Article 10(9) in our Declaration of Conformity sufficient to satisfy that we meet these? I could even support this with a statement/audit summary report from an independent external auditor we use to do our internal audit confirming we meet the requirements.

Part of what I am getting at is that there is an assumption by some in our organization that we absolutely need the ISO 9001 certificate to enter the EU, which requires formal audit by a registrar and ISO 9001 registration. However when it comes to IEC 62304 and ISO 14971 we simply self-declared that we complied to those in our DoC since those are self-declaration standards. Why couldn't we just do the same for the QMS requirements in the MDR and if need be even go as far as self-declaring compliance with ISO 9001 requirements and rely on our internal audit process to provide evidence of conformity?

Would this fly?
 

Marcelo Antunes

Addicted to standards
Staff member
Admin
#5
You do not need any QMS certificate for CE Marking of medical devices, as the requirements in the directives / MDR never required a certificate. You can do the same you do to other standards.
 
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