CE marking and European IVD Directive Current

CE marking and European IVD Directive

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

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

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

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

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)

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

EXAMPLES A Low individual risk and Low public health risk Clinical chemistry analyser Prepared selective culture media B Moderate individual risk and/or Low public health risk Vitamin B 12 test Pregnancy self testing Anti-nuclear antibody test Urine test strips C High individual risk and/or Moderate Blood glucose self testing public health risk HLA typing PSA screening Rubella test D High individual risk and High public health risk HIV blood donor screening HIV blood diagnostic RISK CLASS RISK LEVEL

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

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

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

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.

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

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

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