Evidence of precautions (clinical evaluation report, risk management report)

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yodon

Staff member
Super Moderator
#4
Your English isn't so bad; it's just a topic that benefits from extreme clarity.

The whole purpose of the CER, I believe, is to confirm that your product is sufficiently safe and effective (with considerations to state of the art). One aspect of that is to assess whether or not your instructions (with precautions) are effective. If you're seeing a lot of reports that indicate the precautions are ignored or not understood, you may need to re-think if design can be updated to avoid having to address the precautions altogether or if there are more effective ways to alert the user. Are you having to communicate precautions that other, similar devices don't?
 

Pads38

Trusted Information Resource
#5
A recent CER that I was involved with included a section on 'Warnings and Precautions'. Some of these have come from published scientific literature - some 'general', some specific to our device.

Where this is the case the literature is typically cited, as a reference, along the lines of "Author, AA; Author BB; Author CC; Full Title; Journal; Volume number; pages; year of publication"

As an example:
'Guld, C.; Rosenfalk, A.: Willison, R. G.; Technical factors in recording electrical activity of muscle and nerve in man. Electroenceph. Clin. Neurophysiol.; 28:399-413; 1970.'
 

yodon

Staff member
Super Moderator
#6
A recent CER that I was involved with included a section on 'Warnings and Precautions'. Some of these have come from published scientific literature - some 'general', some specific to our device.
Good input, thanks. I'm curious what the content was. Was it a comparison of warnings and precautions of similar devices or just a list or...?
 

Pads38

Trusted Information Resource
#7
The 'Warnings and Precautions' section was lifted out of the Operators Manual.

This particular device has been on the market for many years so we (as manufacturers) can justify stating that we have 'a good understanding' of the device and it's use.
 
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