Deliverables

Deliverable 2.1 EU Regulatory Framework and International StandardsDownload
Deliverable 1.1 Characteristics, gaps, and best practices of pre-market programmesDownload
Deliverable 1.3 Characteristics and state of play of EFS – DATABASEDownload
Deliverable 1.3 Characteristics and state of play of EFSDownload
Deliverable 2.2 Professional and organizational characteristics of competent authoritiesDownload
Deliverable 2.4 Research report summarizing the current EU regulatory framework for clinical evidence generation for MDs and DHTs and relations with the future EU EFSDownload
Deliverable 2.3 Recommendations for HEU-EFS on state of play of regulatory framework and institutional and organizational characteristics of EU competent authoritiesDownload
Deliverable 3.1 Eligibility criteria for EFSDownload
Deliverable 4.1 Clinical Investigational Plan (1 out of 3)Download
Deliverable 4.1 Template for a Clinical Investigation Plan for EFS clinical investigations involving Medical Devices (2 out of 3)Download
Deliverable 4.1 Checklist for a Clinical Investigation Plan for EFS clinical Investigations involving Medical Devices (3 out of 3)
Download
Deliverable 3.2 Processes, Procedures & TimelinesDownload
Deliverable 5.1 Assessing the Performance of Early Feasibility Studies in the EU – Annex IDownload
Deliverable 5.1 Assessing the Performance of Early Feasibility Studies in the EU – Annex IIDownload
Deliverable 5.1 Assessing the Performance of Early Feasibility Studies in the EU – Annex IIIDownload
Deliverable 5.1 Assessing the Performance of Early Feasibility Studies in the EU – Annex IVDownload
Deliverable 5,1 Assessing the Performance of Early Feasibility Studies in the EU – Annex VDownload
Deliverable 5.1 Assessing the Performance of Early Feasibility Studies in the EU – Annex VIDownload
Deliverable 5.1 Assessing the Performance of Early Feasibility Studies in the EU – Annex VIIDownload
Deliverable 6.2 Methodological DocumentDownload
Deliverable 6.2 Informed Consent Form ChecklistDownload
Deliverable 6.2 Informed Consent Form Template Download
Deliverable 6.2 Insurance Agreement GuidanceDownload
Deliverable 6.2 Master Clinical Trial AgreementDownload

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