Deliverables

WP1

Research and analysis on state of play of premarket programs and implementation barriers to EFS

Deliverable 1.1 Characteristics, gaps, and best practices of pre-market programsDownload
Deliverable 1.3 Characteristics and state of play of EFSDownload
Deliverable 1.3 Characteristics and state of play of EFS – DATABASEDownload

WP2

Research and analysis on regulatory framework, and institutional and organizational characteristics of EU competent authorities

Deliverable 2.1 EU Regulatory Framework and International StandardsDownload
Deliverable 2.2 Professional and organizational characteristics of competent authoritiesDownload
Deliverable 2.3 Recommendations for HEU-EFS on the current state of play of pre-market programs and EFS, of regulatory framework and institutional and organizational characteristics of EU 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 EFS Program (Part 2 – Focus on DHTs)Download

WP3

Methodology development: rationale, processes, and procedure

Deliverable 3.1 Eligibility criteria for EFSDownload
Deliverable 3.2 HEU-EFS methodological frameworkDownload

WP4

Methodology development: evidence requirements, data, and statistical tools

Deliverable 4.1 (1/3) EU EFS Clinical Investigational PlanDownload
Deliverable 4.1 (2/3) Template for a Clinical Investigation Plan for EFS clinical investigations involving Medical DevicesDownload
Deliverable 4.1 (3/3) CIP Checklist for a Clinical Investigation Plan for EFS clinical investigations involving Medical DevicesDownload

WP5

Methodology development: EU EFS program monitoring system

Deliverable 5.1 Assessing the Performance of Early Feasibility Studies in the EU – Annex I – Online Form #1Download
Deliverable 5.1 Assessing the Performance of Early Feasibility Studies in the EU – Annex II – Online Form #2Download
Deliverable 5.1 Assessing the Performance of Early Feasibility Studies in the EU – Annex III – Online Form #3Download
Deliverable 5.1 Assessing the Performance of Early Feasibility Studies in the EU – Annex IV – Online Form #4Download
Deliverable 5.1 Assessing the Performance of Early Feasibility Studies in the EU – Annex V – Online Form #5Download
Deliverable 5.1 Assessing the Performance of Early Feasibility Studies in the EU – Annex VI – Online Form #6Download
Deliverable 5.1 Assessing the Performance of Early Feasibility Studies in the EU – Annex VII – Application formDownload
Deliverable 5.1 Assessing the Performance of Early Feasibility Studies in the EUDownload

WP6

Methodology development: ethical and legal aspects

Deliverable 6.2 Set of templates for the EU EFS Programs – Methodological documentDownload
Deliverable 6.2 Set of templates for the EU EFS Programs – Informed Consent Form ChecklistDownload
Deliverable 6.2 Set of templates for the EU EFS Programs – Informed Consent Form TemplateDownload
Deliverable 6.2 Set of templates for the EU EFS Programs – Insurance Agreement GuidelineDownload
Deliverable 6.2 Set of templates for the EU EFS Programs – Master Clinical Trial Agreement ChecklistDownload

WP7

Testing the methodology: pilot use-cases

Deliverable 7.2 Recommendations for the selection of pilot use casesDownload

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