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”
4
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 B12 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
[email protected]