Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC
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Member States shall ensure that all prospective donors of blood or blood components in the Community are provided with information referred to in Article 29(b).
Member States shall take all necessary measures to ensure that, upon agreement of a willingness to commence the donation of blood or blood components, all donors in the Community provide the information referred to in Article 29(c) to the blood establishment.
1.Blood establishments shall ensure that there are evaluation procedures in place for all donors of blood and blood components and that the criteria for donation referred to in Article 29(d) are met.
2.The results of the donor evaluation and testing procedures shall be documented and any relevant abnormal findings shall be reported to the donor.
An examination of the donor, including an interview, shall be carried out before any donation of blood or blood components. A qualified health professional shall be responsible, in particular, for giving to and gathering from donors the information which is necessary to assess their eligibility to donate and shall, on the basis thereof, assess the eligibility of donors.
1.Member States shall take the necessary measures to encourage voluntary and unpaid blood donations with a view to ensuring that blood and blood components are in so far as possible provided from such donations.
2.Member States shall submit reports to the Commission on these measures two years after the entry into force of this Directive, and thereafter every three years. On the basis of these reports the Commission shall inform the European Parliament and the Council of any necessary further measure it intends to take at Community level.
Blood establishments shall ensure that each donation of blood and blood components is tested in conformity with requirements listed in Annex IV.
Member States shall ensure that blood and blood components imported into the Community are tested in conformity with requirements listed in Annex IV.
Blood establishments shall ensure that the storage, transport and distribution conditions of blood and blood components comply with the requirements referred to in Article 29(e).
Blood establishments shall ensure that quality and safety requirements for blood and blood components meet the high standards in compliance with the requirements referred to in Article 29(f).
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