The following format has been developed jointly by COCIR, EFOMP and ESTRO to meet the requirements of article 78.2 of the BSS Directive.
This document provides guidance to manufacturers how to compile the document for undertakings with adequate information to carry out risk assessments, as required by article 63 and 78.2 of the BSS Directive.

Under Related Documents:

Guidelines For Manufacturers
Template For Information For Undertakings