# Commission Directive 2005/62/EC of 30 September 2005 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards Community standards and specifications relating to a quality system for blood establishments (Text with EEA relevance), Division 3

Extent: E+W+S+N.I.

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 for medical devices and Directive 98/79/EC of the European Parliament and of the Council for in vitro diagnostic medical devices or comply with equivalent standards in the case of collection in third countries.

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Source: https://www.legislation.gov.uk/eudr/2005/62/annex/division/4/division/3 (the official version)
Page: https://openlegislation.uk/eu-directive-2005-62/annex/division-4/division-3
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.