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QMS for device "use" in a Health Institution?

#1
Hi,

Article 5.5 of both MDR & IVDMDR require that "manufacture and use of the devices occur under appropriate quality management systems".
QMS for manufacture is covered by 13485 but is anyone aware of a suitable QMS for use?
 

yodon

Staff member
Super Moderator
#3
I may be wrong, but it sounds to me like this is only applicable when the health institution itself both manufactures ans uses the device; i.e., home-grown devices.
 

Watchcat

Involved In Discussions
#4
I'm inclined to think this is one of many mis-speaks scattered throughout the MDR/IVDR (and other legislations and regulations), why god invented corrigendum. I expect it meant to say "intended use," and to refer to activities like those shimonv cites. It probably means the legal manufacturer's side of the intended use coin, including labeling, not the actual clinical use.

(Really, if you think about it, as long as the medical device is being used in a manner consistent with the labeled intended use, it is being used under the manufacturer's QMS.)
 

Ronen E

Problem Solver
Staff member
Super Moderator
#5
I think @yodon is right.
It's one of the conditions that provide an exemption from the MDR (except the GSPR, Annex I) where devices are manufactured and used only within health institutions established in the Union.

A hospital may operate under e.g. an ISO 9001 QMS.
 
#7
5.5c of the IVDR requires "the laboratory of the health institution is compliant with standard EN ISO 15189 or where applicable national provisions, including national provisions regarding accreditation."
This means that for Health Institution Exemptions [under Regulation (EU) 2017/746], Medical Laboratories accreditation is required or other national provisions (I assume compliance with statutory instruments or other appropriately accredited/certified QMS). No further guidance has been provided by Competent Authorities as to which standards other than ISO 15189 (paradoxically, even ISO 13485) do qualify a QMS as compliant.
 

RobertvanBoxtel

Involved In Discussions
#8
@dgrainger , as you indicated, manufacture and use under appropriate quality management systems.
Let's analyse: Manufacturer: the devices made by the health institute shall be manufactured... For that a QMS is needed comparable to device manufacturers, ensuring traceability and identification of all steps. ISO 13485 can be used, but complete ISO 13485 might be overkill.
Regarding use, this Regulation requires that health institutes uses these devices under an appropriate QMS. As control over these requirements is falling under country competent authority responisibilities, what is deemed appropriate can differ per country. To get an understanding of what appropriate might mean, get in contact with for example hospitals and see what procedures are in place regarding use of medical devices. For example in the Netherlands, a convenant has been set-up several years ago, defining how medical devices during the life time of use are implemented, training on, maintained, disposed of etc. in hospitals.
So more QMSs, relevant for healthacare institutes can be applicable.
 
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