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An invitation to contribute to the revision of the EU legislation on blood, tissues and cells

Legal & Regulatory Affairs Committee

The European Commission is preparing proposals for revision of the European Union’s legislation on blood, tissues and cells (BTC). These changes are intended to protect patients and donors from avoidable risks, strengthen oversight arrangements, support innovation and improve the EU’s resilience to interruptions in BTC supplies. Details of the process are available on the Commission’s website.

The proposals will create new obligations for blood, tissue and cells (BTC) establishments, and the competent authorities that regulate them. It is important that the decisions about adoption of the changes are informed by robust analysis of their benefits and costs.

You are invited to contribute to that analysis by:

  • Completing the online impacts survey
  • Completing the online costs survey by providing information that will inform the calculation of costs associated with the proposals on BTC establishments, such as your organisation,

The survey will be open for responses from 28 June to 24 July 2021. The links to the impact survey and cost survey provided here will require you to complete each questionnaire in one session. If you would like to be able save a partial response and return to it later (or arrange for colleagues to contribute to the same response) then please write to ICF* at to request a pair of personalised links unique to your organisation.

Your responses will be treated as confidential - all the information provided will be anonymised by ICF before it is used in the analysis.

If you have any questions about the survey and cost inquiry, or need assistance with completing it, please write to us at

We hope that you will take up this opportunity to provide your input, and thank you in advance for your contribution to these important reforms.

*On behalf of the ICF, the consultancy retained by the European Health and Digital Executive Agency to assist with the research.