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Public consultation launched on EU blood, tissues and cells legislation

Posted on 30.06.2017


On 29 May 2017, the European Commission launched a consultation regarding the evaluation of EU legislation on blood, tissues and cells.

The main purpose of the consultation is to evaluate whether Directive 2002/98/EC (setting standards of quality and safety for human blood) and Directive 2004/23/EC (setting standards for human tissues and cells), including their implementing (technical) Directives, have met their original objectives and whether they remain fit for purpose.

In broad terms, the legislation aims:

  • To ensure availability of safe blood tissues and cells for EU citizens that need them;
  • To provide citizens with transparent systems that would enhance public confidence, whether citizens are engaged as potential donors or recipients;
  • Define clear lines of accountability for ensuring safety and quality both at service provider and health authority levels.

To access the consultation and further information regarding the Commission’s Roadmap on the evaluation of the EU blood and tissues and cells legislation please click here.

According to the Commission’s website, a Stakeholder Conference will be held on September 20th, 2017 in Brussels. The conference will be used to validate the findings of the consultation activities and to fill in any remaining evidence gaps.

The final evaluation report, taking into account feedback received through the public consultation, is expected to be made available towards the end of 2018. Depending on the results, the Commission will decide whether or not to revise the Blood Directives.

MedTech Europe will be submitting a response on behalf of its members.