1 / 8

Slots/Windows of Opportunities HTA – Medical Devices

Slots/Windows of Opportunities HTA – Medical Devices. Dr. Wolfgang Ecker EUnetHTA , Rome , 30 . 10. 2014. 3 Directives : > Transposition into national law. Directive 90/385/EEC Active Implantable Medical Devices. 2 Regulations : > directly applicable EU- legislation. Regulation

sean-blackburn
Download Presentation

Slots/Windows of Opportunities HTA – Medical Devices

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Slots/Windows ofOpportunitiesHTA – Medical Devices Dr. Wolfgang Ecker EUnetHTA, Rome, 30. 10. 2014

  2. 3 Directives:> Transposition into national law Directive 90/385/EEC ActiveImplantable Medical Devices 2 Regulations:> directlyapplicable EU-legislation Regulation Medical Devices Directive 93/42/EEC Medical Devices Regulation In-vitro-Diagnostic- Medical Devices Directive 98/79/EC In-vitro-Diagnostic- Medical Devices

  3. Considerableimprovement in Clinicalsexpected: NotifiedBodies – betterclinicalqualification NotifiedBodiesunderbetter EU-scrutiny Scrutinyprocedure(pre-/post-market?) Clinical Evaluation (MD) – Life cycleprocess Performance Evaluation (IVD) – betterdefinedprocess Scientific infrastructure: Device/expert Panels; RefLabs Long term: Registries, PMCF, PMPF Betterclinicaltransparency But: Still weakness in terminology! (Efficacy? Effectiveness?) MD - Progress on Clinicals EUnetHTA, Rome, MD-HTA-Slots

  4. HTA – MD Interaction:Governance Device/Expert Panels MS CompetentandDesignatingAuthorities MD CoordinatingComittee (MDCG) Joint Assessment Team (JAT) (EU Reference Labs for IVDs?) Device Registry evaluations HTA toserveasexpertsfor Expert/Device Panels and/orfor MS, MDCG, JAT:

  5. ScrutinyDiscussion: pre-/post market? Device/Expert Panels + EU RefLabs MS-DA JAT Expert Panel? Clinical Evaluation Plan + Report Clinical Evaluation Assessment Report MDCG? COM? MDCG? COM? Clinical AUDIT Notified Body PMCF; Updates of Clinical Evaluation; Recertification Manufacturer Notified Body Pre- Post-market Clinical AUDIT MS-DA JAT Expert Panel? HTA in agreementwith MF/NB orasexpertsfor DP or MS/JAT EUnetHTA, Rome, MD-HTA-Slots

  6. HTA – MD Interaction:Guidance Common Specifications (CS): Clinical Investigations Clinical Evaluation Post Market Follow-up (PMCF) SummaryofSafetyand Clinical Performance Data (SSPD) Templates Harmonised Standards? HTA aspartof Expert/Device Panels couldcontributetoGuidanceforspecificdevicetypes:

  7. HTA – MD Interaction:Training Literature reviews Gradingqualityofclinicalinvestigations Currentstateoftheart in medicine(HTA, EBM) HTA tocooperate on web-basedtrainingfor MD-stakeholders

  8. ThankYou!

More Related