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Current EU and Global Activities in the „Clinicals“

Current EU and Global Activities in the „Clinicals“. Dr. Wolfgang Ecker Federal Ministry of Health, Austria Chairman of EU WG CIE. 3rd National Conference for Medical Devices, 13/14 April 2010, Rome. EU Working Group on Clinical Investigation and Evaluation.

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Current EU and Global Activities in the „Clinicals“

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  1. Current EU and Global Activities in the „Clinicals“ Dr. Wolfgang Ecker Federal Ministry of Health, Austria Chairman of EU WG CIE 3rd National Conference for Medical Devices, 13/14 April 2010, Rome

  2. EU Working Group onClinical Investigation and Evaluation COM + Member States + NB + Industry CIE EU WG on Clinical Investigation and Evaluation (incl. PMCF) GHTF SG 5 ISO/CEN/CLC Clinical Safety and Performance

  3. Request for high quality clinical trials will raise! • Upgrade of Clinical Evaluation in the Revision ofthe Medical Device Directives 2007/47/EC • HTA/EBM usebyhealthcarefinancers

  4. Acceptance in Health Care/Remuneration HTA Health Technology Assessment Medico-(Economical) Analysis Market Market PMCF Conformity Assessment/CE Premarket Approval Pre-Market Medical Evaluation Clinical Evaluation/Performance Evaluation Technical/Preclinical/Analytical Evaluation Medical Devices/IVD‘s

  5. Important documents for medical devices EU – Legal System New Approach Global Approach Medical Device Directives MEDDEV‘s + other Interpretative doc‘s COM-legislation Harmonised Standards GHTF-Guidelines Nat. Medical Device Act Decrees, Ordinancies

  6. Directive 90/385/EEC Active Implantable Medical Devices EU Medical Device - Directives Pacemakers; ICD‘s Implantable Infusion pumps Artificial hearts ... + software and accessories NMR, US, X-ray, Hip-implants, ECG, EEG, Intravascular catheters, Stents, syringes, IOL, RR, med. lasers, med. software Directive 93/42/EEC Medical Devices Directive 98/79/EC In-vitro-Diagnostic- Medical Devices HIV-tests, Hepatitis-tests, Pregnancy-tests, Lab-Automats, Reagents, Calibrators, Control materials Prim. specimen receptacles ...

  7. Clinical Evaluation: What do Directives 93/42/EEC and 90/385/EEC say (after Revision 2007/47/EC)?

  8. Revision of 93/42/EEC and 90/385/EEC CLINICAL EVALUATION = Core Element of 2007/47/EC!! 3.Layer Conformity Assessment 2.Layer Documentation 1. Layer Clinical Data/Evaluation Flow Model

  9. 3 layer model of clinical evaluation in EU medical device regulation (+) 3.Layer Conformity assessment Design Modules QM Modules Techn Doc/STED/Design dossier incl. clinical data and Clin. Evaluation Report + preclinical data + Risk management output Documentation of Clinical Evaluation Process + Preclinical Evaluation + Risk management 2.Layer Documentation Conformity with ER Clin Invest Route Demonstration of conformity with clinical ER Clinical Evaluation Literature Route Clinical Data 1.Layer Clinical Model Clin Exper. Route Combin Route Updates of clin eval; ev. PMCF Manuf. Claims; risk mgt output State of the art EN's, Techn+other Eval

  10. Clinical Investigation: What do Directives 93/42/EEC and 90/385/EEC say (after Revision 2007/47/EC)?

  11. Clinical InvestigationTable of correspondence of Directives Aspect Dir 93/42/EEC Dir 90/385/EEC Definition of device for CI; clinical data Art. 1.2. (e) + (k) Art. 1.2. (e)+(k) if Art. 10+Ann. 6 Free movement if Art. 15+Ann. VIII Art. 10 Art. 15 Administrative Procedures for CI Ann. VIII Ann. 6 Statement for CA + Documentation Clinical Evaluation Ann I.I.5a+ Ann 7.1. Ann I.I.6a+Ann X.1 Clinical Investigation Ann. X.2 Ann. 7.2.

  12. Revision Directive 2007/47/EC • Clinical Investigation (Art. 15/10; Ann VIII/6, X/7) Manufacturer/Sponsor: • Notification of SAE to all MS concerned • Notification of finalisation to MS concerned; in case of early termination with justification! If for safety reasons > all MS + COM! • Declaration/Documentationaccompanying notification of a Clin. Investigation (Ann. VIII/Ann. 6) • Draw EUDAMED-Code for Clinical Investigation(from May 2011; optional from 2010)

  13. Draft

  14. Draft

  15. Revision Directive 2007/47/EC MS: • MS Info-Exchange (refusal, halt, sign. modification, temp. interruptionof CI) • Inclusionof CI-module in EUDAMED • EthicsCommitteehastoevaluate Clinical Investigation Plan

  16. CIEClinical Investigation andEvaluation • PreparationofEUDAMED Clinical Investigation Module • Stage 1: administrative data > identifier • 1a: general administrative data > identifier • 1b: Art.15-6/7 procedures(refusal, halt, sign. modification, temp. interruptionof CI; earlytermination on safetyreasons) • Stage 2: SAE-Reporting • Stage 3: (fulldossiers)?

  17. Informed Consent General Safety/Ethical and Procedural Aspects Investigator‘s Brochure Literature Review EN ISO 14155-1 Documents Final Report Clinical Investigation Plan Clinical Investigator Sponsor EN ISO 14155-2 Roles CRF Monitor

  18. Clinical Investigation of Medical Devices Essential Requirements Safety Performance Preclinical and Clinical Experiences Risk Analysis Training Investigator‘s Brochure EN ISO 14155 Harmonized Standards Science Clinical Investigation Plan CRF‘s Literature Review EN ISO 14155 Directives Ethics Organisation Finances Informed Consent; Insurance; Special Target Groups; Roles; Documentation; Decl. of Helsinki EN ISO 14155 Model of Financiation of MD Administrative Procedures Ethics Committee Notification to CA 60-Day Procedure CE marked MD DIRECTIVES (Inspections) Administrative Procedures Ethics Committee Notification to CA 60-Day Procedure CE marked MD Communication Decisions EUDAMED DIRECTIVES (Inspections; Fees) SAE/Changes/(early) Termination DirectiveMEDDEVEN ISO 14155 Final Report EN ISO 14155

  19. Art. 10/15Administrative Proceduresfor Clinical InvestigationsDir. 90/385/EEC and 93/42/EEC MF/Sponsor Ethics Committee(s) Statement Ann. 6/VIII.2.2 (Documentation) Ann. 6/VIII.3.2 Notification Art. 10/15 Competent Authority AIMD; MD: Class III, Class IIa+IIb-Implantable or long-term invasive (TACIT) APPROVAL (<) 60 d Start of Clinical Investigation

  20. Statement accompanying notification of a clinical investigation(Ann. 6 of 90/385/EEC and Ann. VIII of 93/42/EEC) • (Notification form) • Clinical Investigation Plan (CIP) incl. CRFs • Investigator‘s Brochure • Votum of Ethics Committee(s) • Material for informed consent • Confirmation of insurance of subjects • Declaration to Essential Requirements • Statement/Declaration concerning components of human/animal origin

  21. Directive 93/42/EEC Directive 90/385/EEC Clinical Investigations: Where can you find helpful documents?

  22. Documents • Directives • National Legislation/Administration and Guidance • Declaration of Helsinki • Harmonized Standards • EN ISO 14155-1 and 2; forthcoming: FDIS (GCP for Medical Devices) • 14971; 10993; 60601; 14630; 10555; … • Horizontal Guidance (MEDDEVs: Clinical Evaluation; PMCF; …) • Vertical Guidelines (Coronary stents; …) • FDA: • IDE/PMA-Guidelines • summaries of safety and effectiveness • HTA-Reports, Cochrane-Reports • Clinical/Scientific Societies

  23. CIEClinical Investigation andEvaluation • New/updatedGuidance • Guidance on SAE-Reporting/Forms • Guidanceon Clinical Investigations(> GHTF) • Update of PMCF-Guidance(> GHTF) • Strategic Development • RecastClinicals • BuildupCooperationwith • Clinical Societies • (Implant) Registries • EUnetHTA(Joint Action HTA of DG SANCO) • Rapid Clinical Task Force(s)/Device Panels? • Regulator‘s Forum for (specific) multinational CI‘s

  24. EN DIS ISO 14155Clinical investigation of medical devices for human subjects — Good clinical practices • Scope • Normative References • Terms and Definitions • Ethical Considerations • Clinical Investigation Planning • Clinical Investigation Conduct • Suspension, Termination and Close-out • Responsibilities of the Sponsor • Responsibilities of the Principal Investigator

  25. EN DIS ISO 14155Clinical investigation of medical devices for human subjects — Good clinical practicesAnnexes • Clinical Investigation Plan (CIP) n • Investigators Brochure (IB) n • Case Report Forms (CRF) i • Clinical Investigation Report i • Essential clinical investigation documents i • Adverse event classification decision tree i ZA Relationship between this European standard and the Essential requirements of EU Directive 93/42/EEC i Bibliography Tables n ... normative; i ... informative

  26. GHTF SG5 Guidelines: SG5/N2R8:2007 Clinical Evaluation SG5/N1R8:2007Clinical Evidence – Key DefinitionsandConcepts SG5 ….. Post Market Clinical Follow Up Studies SG5 ….. Clinical Investigations SG2/5 …. SAE-Reporting SG1/5 …. Clinical Evaluation of IVDs

  27. HTA

  28. FDA/CDRH - Guidance

  29. ThankYou! 3rd National Conference for Medical Devices, 13/14 April 2010, Rome

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