If a company is legal manufacturer for a simple class I non sterile device (a cable for example) and subcontracts manufacture/labelling/packaging to another company, what manufacturing related technical documentation would the legal manufacturer be expected to hold? Manufacturing procedures would belong to the subcontractor for example but surely the legal manufacturer would be expected to have all of the information in Annex II of MDR available including information on manufacturing methods, procedures, inspection criteria, critical processes etc. along with a pFMEA for the products.
Expectations for manufacturing info for Class I non sterile device
- Thread starter Awadine
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Is this really a "device" (I can't imagine how a cable is a device).
Also unsure what you mean "to hold." If something is required by regulation, whether you have it in your facility or you ensure it's available elsewhere, it's still your responsibility.
Most of my clients that use CMs do not take the responsibility of keeping the manufacturing procedures in their document control system. They ensure the CM has proper controls to manage the procedures (and have a Quality Agreement in place to require notification before any changes are made).
Also unsure what you mean "to hold." If something is required by regulation, whether you have it in your facility or you ensure it's available elsewhere, it's still your responsibility.
Most of my clients that use CMs do not take the responsibility of keeping the manufacturing procedures in their document control system. They ensure the CM has proper controls to manage the procedures (and have a Quality Agreement in place to require notification before any changes are made).
Thanks @yodon
Cables can be accessories if they are specific to a medical device and not off the shelf consumer products. But that was just an example of something you could easily subcontract the entire manufacturing operation for and for it to be a self declared Class I device.
By ‘hold’ I mean part of your technical documentation.
So from what you are saying, it sounds like you would expect the legal manufacturer to have visibility to and possibly to have approved the manufacturing procedures. Is that correct?
If all a technical file for a class I non sterile device had to say under manufacturing information was: “ product is manufactured by company Y“ with no information on manufacturing processes and their validation, their adjuvants, the continuous monitoring and the final product testing, is that sufficient for a Class I device? For me the answer is a clear no and the legal manufacturer would still need to be able to describe the processes in detail and reference manufacturing procedures. But maybe I am wrong.
Cables can be accessories if they are specific to a medical device and not off the shelf consumer products. But that was just an example of something you could easily subcontract the entire manufacturing operation for and for it to be a self declared Class I device.
By ‘hold’ I mean part of your technical documentation.
So from what you are saying, it sounds like you would expect the legal manufacturer to have visibility to and possibly to have approved the manufacturing procedures. Is that correct?
If all a technical file for a class I non sterile device had to say under manufacturing information was: “ product is manufactured by company Y“ with no information on manufacturing processes and their validation, their adjuvants, the continuous monitoring and the final product testing, is that sufficient for a Class I device? For me the answer is a clear no and the legal manufacturer would still need to be able to describe the processes in detail and reference manufacturing procedures. But maybe I am wrong.
chris1price
Trusted Information Resource
As the legal manufacturer you would be expected to hold the specifications for the device and that these are passed to the CMO. You would also be expected to ensure that the product is made to these specifications, either through final inspection or by audit. At a last resort, approving the final release documentation.
Hi - I classify a cable as a replacement part. If functionality I would agree it could be a Class 1 cable holding the technical file with supporting data as the LM. Question I have for this thread is for clarity. We have a cable which is a spare part. Individuals are trying to claim classification for this part as class I. Shipped individually is a spare part as there is not functionality nor clinical functionality would be a spare/replacement. If this connecting cable is shipped with the system - to connect a module/sensor this would have functionality and be classified with the system (IIa) as a whole and maintain the STED file accordingly- correct? Would you be in agreement with this assumption. Please advise. Thank you.
If the cable is shipped with the system where the system as a whole meets criteria to be class IIa, and replacement cables are then available to be supplied separately to users of the system - the replacement cable is a spare part and does not need to be separately classified, providing its specification and function remains the same as the cable it is intended to replace and it is not intended to alter the performance of the system it is used with.
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