CE marking and European IVD Directive

1. CE marking and European IVD Directive

2. Current regulatory system • Joint Action Plan • Signal Detection Proposals for change • Classification • Clinical evidence • In house manufacturing • Companion diagnostics

3. Medical device regulations investigation action Competent Authority Notified Body compliance post market surveillance vigilance European market Harmonised Standards/CTS “presumption of conformity”

5. Joint Action Plan • Qualifications of NB re-assessed • Joint Audits of NB • Unannounced visits of manufacturers • Vigilance teleconference of Competent Authorities

6. Signal Detection • Significant improvements in adverse incident reporting by UK healthcare • New signal detection software • Increased focus on signals

7. Proposed new regulations • Proposals published in September 2012 • Medical Devices Regulation • IVD Regulation • Move to risk-based classification rules • Clinical evidence & clinical investigation requirements • Changes to ‘in-house’ exemption • Companion diagnostics • Many other aspects aligned across both regulations (notified bodies, unique device identifiers)

9. Classification rules • IVDs are currently categorised into two main lists: • high risk tests used in blood screening, • a mixed list of other medium risk tests • home tests, and • all other tests • New system will use rules to classify devices as A, B, C or D

10. RISK

11. Clinical Evidence • Clinical evidence now required (though exceptions possible) – documented in a clinical evidence report • Concepts of analytical performance scientific validity, and clinical performance introduced • Post-market surveillance required to keep clinical evidence up to date

12. Clinical Evidence - Terminology Analytical performance: the ability of an IVD to detect or measure a particular analyte Scientific validity: the association of an analyte to a clinical condition or a physiological state Clinical performance: the ability of an IVD to give results that are related to the clinical condition/ physiological state in the target population and intended user

13. Clinical evidence vs clinical utility Scientific Validity CLINICAL UTILITY CLINICAL EVIDENCE Clinical Performance Analytical Performance

14. Clinical performance studies • New concept – when gathering data to support CE marking • General requirements on all studies • Specific requirements – including competent authority approval – on: • ‘interventional’ studies – affecting patient management decisions; and • studies that involve invasive procedures or other risks for patients.

15. The ‘in-house’ exemption • Currently – blanket exemption for all IVDs manufactured and used within same health institution • Commission’s proposal: • single quality management system • accreditation to ISO 15189 • vigilance reporting • exclusion of highest risk (‘class D’) IVDs

16. Companion Diagnostics • Class C • “specifically intended to select patients with a previously diagnosed condition or predisposition as eligible for a targeted therapy” • The Notified Body will consult with the county’s medicines authority

17. Thank you for listening Steve Lee 020 3080 7309 Stephen.Lee@mhra.gsi.gov.uk