Safeguarding public health
The regulation of IVF
media
Name: Dr Rosalind Polley
Date: 2 February 2011
© Crown copyright 2005
Safeguarding public health
Regulations
Regulated under the Medical Device Directive
93/42/EC from 2008
Class III when they contain medicinal substances,
animal tissues or human blood derivatives
MEDDEV 12-1 rev 6 vigilance guidelines
undergoing revision to include IVF/ ART
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CE marking
Medical Device Manufacturer
Class IIa/b +III
Approval to conduct CI sought
CA
Conducts Clinical Investigation
/Performance Evaluation if needed
Produces technical file
Employs Notified Body
Drug CA/EMA
EMA
CA conducts market surveillance on
devices placed on the market
NB conducts Conformity
Assessments
Approval by NB
Notified Body Issues
certificate where
conformity is proven
Conformity
not proven
Signs declaration of conformity
CE marked
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Placed on the EU market
Post Market Surveillance inc
Defined Adverse Events Reported
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Safeguarding public health
Expertise of Notified Bodies
Notified bodies must have appropriate expertise to
perform conformity assessments. Assessed by MHRA
Review clinical evidence presented by manufacturer.
Must meet Essential Requirements (Annex I of MDD
93/42/EEC)
Review impact of any changes to validity of CE mark
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Safeguarding public health
Long Term Surveillance
Directive relates to lifetime of the device, not patient
Manufactures should have a plan for Post Market
Surveillance including Clinical Follow-Up
Individual clinics may report problems with media, in
generating pregnancies or long term health of
children to the MHRA
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Safeguarding public health
Next Steps
Potential for research: linking of health outcome
data for children born via IVF to HFEA data sets
Encourage User reporting. Ensure adequate
records maintained by clinic.
Vigilance reporting by manufactures – duty to
report
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Safeguarding public health
What is the need for guidance on
reporting?
Vigilance and user reporting
Based on MEDDEV 12-1 rev 6
vigilance guidelines
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Safeguarding public health
Thank you
Any Questions?
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© Crown copyright 2005
© Crown Copyright 2011
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© Crown copyright 2005