Product Training Requirements for Users of Product(s)

Weeder

Involved In Discussions
#1
Besides providing adequate instructions for use, is there a QSR or ISO or CE requirement that manufacturer deliver product training to the user?

If OEM chooses to provide training, can they determine the adequacy of the training and who delivers the training? for example, can the training be delivered by the distributor on their behalf? Does the OEM have responsibility to ensure the distributor is qualified to deliver the training?
 
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SteveK

#3
Besides providing adequate instructions for use, is there a QSR or ISO or CE requirement that manufacturer deliver product training to the user?

If OEM chooses to provide training, can they determine the adequacy of the training and who delivers the training? for example, can the training be delivered by the distributor on their behalf? Does the OEM have responsibility to ensure the distributor is qualified to deliver the training?
In the Essential Requirements (Annex I) of the Medical Device Directive 93/42/EEC (CE marking requirement) there is:

13. Information supplied by the manufacturer

13.1. Each device must be accompanied by the information needed to use it safely and properly, taking account of the training and knowledge of the potential users, and to identify the manufacturer.

I am not aware of any actual requirement that a manufacturer conduct medical device training themselves via any Directive or Standard (though our company offers this and we supply a competency statement/checklist for a particular device).

In the UK the NHS have their own internal requirements, based on their policies etc e.g.

http://www.icid.salisbury.nhs.uk/Cl.../Pages/MedicaldevicetrainingCP.aspx#appendixf

Steve
 
#4
Training requirements are also driven by the risk management process and, nowadays, should take into account the usability process.

Also, many of the professional groups that clinicians are members of, set training, experience and qualification requirements. So for a manufacturer of, say, an x-ray machine the radiologist's association may have particular expectation of training required for a new machine.
 

Weeder

Involved In Discussions
#5
That was helpful. What I gather is the manufacturer has to determine the need for training and how it will be delivered. And then of course, document the training. Thanks everyone.
 
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