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Requirement to manufacture under a quality management system

Michael Ayers

Starting to get Involved
#1
I would really appreciate any advice on the following.

One of the key requirements of the new regulations is that the manufacture of a medical devices occurs under an appropriate quality management system (e.g. 13485).

Many hospitals manufacturer either custom devices, or devices used only in-house (therefore applying the Health Institution Exemption). However, it is likely that only part of the hospital will be registered to a suitable quality management system.

What is the specific meaning of the phrase “under an appropriate quality management system”?

Can a hospital department which is registered under a quality management system (e.g. Medical Physics), act on behalf of another department which is not registered under a quality management system (e.g. Ophthalmology) for the purpose of manufacturing devices for the non-registered department?
 
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chris1price

Trusted Information Resource
#2
For a custom-made device, you need to comply with Annex XIII. This does not require a Quality Management System, just that the device meet the Annex I, General Safety and Performance Requirements.

If its not a custom-made device, you will need to show evidence of a QMS as part of the CE Marking process. The requirements are laid out in Article 10. I would say Medical Physics could do this on behalf or Ophthalmology, however you would need to have agreements in place to ensure all the necessary elements of the MDR are in place. This would be akin to non-certified company subcontracting the processes to a certified contractor.
 

Michael Ayers

Starting to get Involved
#3
Many thanks for the response. With regards to custom-made devices, what makes such devices exempt from Article 10.9, which says

Manufacturers of devices, other than investigational 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.

Custom-made devices are stated as being exempt from certain obligations in Article 10, but I cannot find where they are stated as being exempt from having a quality management system in place.


In the case of Medical Physics being subcontracted by another department to manufacturer a device, would this still be possible if that non-registered department were physically doing the manufacturing?
 

chris1price

Trusted Information Resource
#4
The more you read the MDR, the less clear it becomes...… However this is my reasoning. Starting with Article 10-9. The paragraph starts

Manufacturers shall ensure that procedures are in place to keep series production in conformity with the requirements of this Regulation. (This is also in para 32 of the preamble). By definition, a custom made device is not "Series Production", they are one-offs.

When I look at conformity assessment procedures, the procedure for Custom Made Devices (Annex XIII) makes no mention of having a QMS. in contrast, the first line of Annex IX starts "The manufacturer shall establish, document and implement a quality management system as described in Article 10(9)".

That was my thinking, however, having read through a few times, I am not so sure and would welcome others to comment. My opinion could easily be changed.
 

twanmul

Involved In Discussions
#5
You're referring to the health institution exemption requirements within Article 5(5). The MHRA (I'm assuming you're in the UK) went out to consultation with this draft guidance last year here. Unfortunately there hasn't been a follow up issued to this draft guidance. Further to this, the sections on QMS and on custom made devices may not be helpful for your specific information but hopefully does give you a starter.

What is required for medical device manufacturers isn't by definition needed for exemption:

With the exception of the relevant general safety and performance requirements set out in Annex I, the requirements of this Regulation shall not apply to devices, manufactured and used only within health institutions established in the Union, provided that all of the following conditions are met...
As such, you can ignore the requirements of Article 10 providing you can meet the conditions of exemption (one of which is the appropriate QMS). It may be that you need to undertake a gap analysis of your existing QMS against those suggested within the draft guidance published by the MHRA.
 
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