Report on WG Clinical Investigation and Evaluation

(CIE)

Wolfgang EckerFed. Min. of Health, Austria

Chairman CIECracow, 28-10-2011

CIEWork Plan - Achievements

Help develop regulatory system:Contributions to WG Recast wish list; options paper

Develop guidance:MEDDEV SAE-Reporting + summary tab form

MEDDEV PMCF-studies in final stage (GHTF)Individual SAE-reporting form in prep (GHTF)

EUDAMED CI module in operation:Yes and constantly improvingUnique identifier Electronic CI notification form for easier upload in prep

CIEWork Plan - Targets

Mirror group of SG 5:Last GHTF Guidance to transpose > PMCF-studiesContributions to SG1/SG5 TF on Clinical Evaluation of

IVDsContributions to SG2/SG5 TF on SAE-Reporting (esp

individual SAE-reporting form)

Exchange of opinions/experiences/best practice:Regularly done at CA-only sessions

CIE homepage:Yes, but it‘s not so easy to find us!

CIEWork Plan - Achievements

CIEWork Plan - Targets

Support Recast:Ready to help with specific drafting tasks

Ressource sharing/VHP/CAP:pilots to be planned for recast VHP/CAP?

Administrative CooperationForum for discussing critical issues in multinational trialsDevelop best practice guidance

Surveillance program:Implementation of 2007/47/EC in practice? MF/NB?

Program development together with COEN and NBOG

CIENext Steps

CIEWork Plan - Targets

Cooperation with Clinical societies, Registers, Pharma, HTA, Patients organizations, other stakeholders:

First steps (Orthopedics, Registers, Pharma [COM, HMA/CAMD], HTA) done

Define modalities and areas of cooperationIntensify contacts and cooperationIncrease transparency and active PR

Training, e-learning:First trial 2012?

CIENext Steps

Thank You!