Class I MDR Article 10 – QMS

Sue789

Involved In Discussions
#1
I am working with a small Charity in the UK producing one Medical Device and have a couple of questions for MDR Article 10 Section 9. The Charity have no plans to be audited to ISO 13485.
(c) Responsibility of Management – do I need to cover the whole of ISO 13485 Clause 5?​
(d) Resources - do I need to cover the whole of ISO 13485 Clause 6 or is sections on Provision and Human Resources (6.1 & 6.2) sufficient or less?​
I am used to writing QMS systems but not streamlining for Class I devices and being a charity what is the minimum I could get away with for the requirements of Responsibility of Management and Resources (I am ok with the control of suppliers/sub-contractors)?

Thanks in advance.
 
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shimonv

Trusted Information Resource
#2
Hi Sue,
As you probably know, the implementation of MDR has been postponed to May 2021. This will give extra time to build a skinny QMS.
You don't have to implement ISO 13485 but it's the state of the art, so this is your benchmark.
With regards to Management Responsibility, most of the staff is implemented in the Quality Manual, with the exception of management review. As for management review you can do the bare minimum, and in one annual session.
With regards to resources, again ISO 13485 is your benchmark. I assume the headcount is minimal and the same goes for qualifications. You would need to look at some other SOPs and strip down what you can.

Shimon
 
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