Regulatory framework: what applies today
Directives 2002/98/EC (blood) and 2004/23/EC (tissues and cells) and their implementing acts remain applicable today, together with the national implementing rules.
Regulation (EU) 2024/1938 on substances of human origin has been in force since 6 August 2024 and is generally applicable from 7 August 2027; some provisions follow different deadlines, earlier or later, and transitional rules are provided for. Until 7 August 2027 the new regulation is not the generally applicable regime.
This page is not legal advice nor an exhaustive list: the official sources (the Official Journal of the European Union and national legislation) prevail. Deadlines should be checked when planning.
Who it is for
- Tissue and cell banks and cord blood banks
- ART centres and laboratories handling gametes and embryos
- Transfusion services and processing laboratories
Common critical points
- Understanding which requirements apply today, which will change, and from when
- A quality system and documents built for the current regime, to be reviewed going forward
- Traceability, vigilance and management of adverse events
- Relations with the competent authorities and critical suppliers
What ICMED does
- Map of current requirements, with the regulatory sources cited
- Analysis of the differences between the existing system and the incoming framework, without anticipating its applicability
- Step-by-step adjustment plan, with dates tied to the official deadlines
- Update of procedures and documents when the new requirements become applicable
- Training and internal audits
Collaboration path
- Assessment — map of current requirements and of the existing system
- Work plan — adjustment steps tied to the official deadlines
- Implementation — update of procedures and documents
- Audit and verification — internal audits and corrective actions
- Maintenance — monitoring of regulatory updates, if requested
Indicative deliverables
- Map of current requirements and expected differences, with sources
- Step-by-step adjustment plan
- Updated procedures and documents
- Internal audit report
Actual content depends on the facility and the agreed scope.
Optional links
Each ICMED service can be chosen on its own: consulting does not require adopting IAAPP or enrolling in training courses.
ART / IVF
Quality in assisted reproduction centres.
Cord blood banks (FACT-NetCord)
Accreditation of cord blood banks.
Biobanks
Quality system and ISO 20387.
Transfusion services
Quality system and transfusion regulations.
IAAPP — optional
ICMED's software platform for documents, audits and non-conformities. Not required for consulting.
Path and deliverables are indicative: they are defined after the assessment, based on your facility. The outcome of accreditations, authorisations, certifications or inspections depends on the decisions of the competent bodies and cannot be promised by ICMED. The rules and standards mentioned are not an exhaustive list of the applicable requirements.
Review the regulatory picture for your facility
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