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.
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.