MDR Conformity Assessment for a Class 2a device - Production Quality Assurance

chris1price

Trusted Information Resource
#1
Hi, I'm hoping someone can double check this for me. I am comparing the conformity assessment routes for a Class 2a device under the new MDR. In particular, comparing Annex IX (full quality assurance) with Annex XI Part A (Production Quality Assurance). As I see it, the key difference is that under Annex XI Section 6.2 the items listed in section 2.2 Paragraph C of Annex IX are not required. These include: Design Controls (inc V&V), Risk Management and Clinical Evaluation (inc Post Market Clinical Follow-up).

Am I correct, a Clinical Evaluation is not required?

Thanks
Chris
 
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Thulasidharan

Starting to get Involved
#2
Hi Chris,

As per Article 52(6)

Manufacturers of class IIa devices, other than custom-made or investigational devices, shall be subject to a conformity assessment as specified in Chapters I and III of Annex IX, and including an assessment of the technical documentation as specified in Section 4 of that Annex of at least one representative device for each category of devices. Alternatively, the manufacturer may choose to draw up the technical documentation set out in Annexes II and III coupled with a conformity assessment as specified in Section 10 or Section 18 of Annex XI. The assessment of the technical documentation shall apply for at least one representative device for each category of devices.

As per Annex II & III - Design Controls (inc V&V), Risk Management and Clinical Evaluation (inc Post Market Clinical Follow-up) are essential requirements.
 

chris1price

Trusted Information Resource
#3
I agree with what you are saying about Annex II and III. However....

……. when you get to Annex XI 6.2 the QMS requirements exclude design, risk and clinical (ie point c of Annex IX 2.2).

Furthermore, when you get to Section 7, Surveillance, it misses out point 3.5 of Annex IX, this is the requirement for the NB to review the Clinical evaluation and PMCF.

So as I understand it, Annex II and III says you should perform risk, design control and clinical, however the NB will not review them!
 
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