Minimum Activity Data Set for Blood and Blood Components
The EDQM, in collaboration with the European Commission (DG SANTE), is coordinating a project to define a minimum activity data set for blood and blood components, in line with Article 41 of the EU SoHO Regulation.
Background
There is an identified need for harmonising and co-ordinating activity data collection and reporting for blood and blood components in Europe.
Despite the extensive efforts by all stakeholders involved, currently, there are multiple overlapping data collection and reporting exercises, often with differing formats, definitions, and timeframes. This creates inefficiencies, response fatigue and limits the comparability of activity data across Europe.
A harmonised minimum activity data set, as required under the framework of the EU SoHO Regulation (Article 41), provides an opportunity to change this. The data set will therefore also be an important input for further legal and IT development to implement the new Regulation.
A standardised minimum activity data set can serve as a common reference point for stakeholders and authorities, and form the foundation for more structured and reliable data collection and reporting for blood and blood components in Europe – with the objective to support donor and recipient protection, monitor the sufficiency of blood and plasma supply, promote transparency and oversight of activities, and minimise duplication while improving efficiency.
Guided by the principle of “collect once, use often”, the minimum data set aims to maximise the value of the information collected, reduce the reporting burden and create a sound basis for European data-collection and reporting on blood and blood components.
Working Group
A working group has been established under the European Committee on Blood Transfusion (CD-P-TS), with nominated experts from Council of Europe member states. The group is extended to professional associations in the field and works closely with DG SANTE and the SoHO Coordination Board (SCB) Working Groups (supply, traceability and vigilance). The SCB will ensure the data set is used for the further legal and IT development under the SoHO regulation, and it’s Working Groups will develop in parallel a common approach on how these data sets can be collected, compiled and used.
Timelines
| Output | Date |
|---|---|
| Working Group Meeting (in person) | 7 and 8 October 2025 |
| Minimum activity data set – Initial Draft | January 2026 |
| Minimum activity data set – Consultation | March 2026 |
| Working Group Meeting (in person) | March/April 2026 |
| Minimum activity data set – Proposal | June 2026 |
The dates listed are indicative and subject to change.
Stakeholders will be invited to provide feedback on the draft dataset during the consultation phase 2026. Your input will be essential to ensure the dataset is practical, meaningful, and technically sound. Further details on the consultation process will be communicated and posted here when available.
- Terms of Reference for the Working Group
For questions or further information, please contact: [email protected]