UKRP to what level should you audit Class I Technical Documentation?


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The obligation placed on the UKRP is quote;

[to] ensure that the declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer.

For a Class IIa/IIb or Class III device where a Design Examination/Conformity Assessment Certificate exists and a Notified Body has certified the sufficiency of the technical documentation that is simple to comply with.

However, in the case of a Class I device that has been self certified what is the minimum expectation for the contents of the technical documentation? and what should it be audited against?

Something like NB-MED/2.5.1 rev 4 - Technical Documentation, perhaps?

I'm interested to hear what others are doing?
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