Assessment of Technical Information of Annex II Medical Devices

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Marc

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#2
Anyone medical device folks here with comments or something to share?
 
R

Roland Cooke

#3
Well it's an excellent report, the latest in a series from the Dutch.

The things that jumped out at me were
a) how few technical files are submitted with little or nothing wrong with them
b) that clinical data is a key reason for non-conformance


That matches my typical findings perfectly.....


I think the MHRA have issued a couple of similar things over the years, but in less depth, I've sent a request to them to see if they can send anything.

Typically MHRA focussed on files for Class I devices that they had requested be submitted to them (since we NBs deal with higher Classes), and the results were similar, but generally worse.

That's not surprising actually as:
a) Class I manufacturers often have a lower understanding of regulatory requirements
b) MHRA's request for documentation may have been prompted by misgivings at their end


I may re-post when I have studied the report in greater depth. Thanks very much for posting it Rob.
 
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