Is a site visit required for Module C2?

A site visit for assessment of the internal production control is not required.  Typically, a visit will have to be undertaken by the Approved/Notified Body to select samples for Product Checks. This can occur at the production site, or any other site designated by the manufacturer, provided there are sufficient products to allow appropriate sampling.

Atypically and under extraordinary circumstances, the Approved/Notified Body can consider a remote means of sampling – such as review of production records / stock and virtual-video sampling.

 

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