Division 3

Only reagents and materials from approved suppliers that meet the documented requirements and specifications shall be used. Critical materials shall be released by a person qualified to perform this task. Where relevant, materials, reagents and equipment shall meet the requirements of Council Directive 93/42/EEC^f1 for medical devices and Directive 98/79/EC of the European Parliament and of the Council^f2 for in vitro diagnostic medical devices or comply with equivalent standards in the case of collection in third countries.