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 Presentation title Name Slide 2 Date © Crown copyright 2005
CE marking Medical Device Manufacturer Class IIa/b +III CA Approval to conduct CI sought Conducts Clinical Investigation /Performance Evaluation if needed Co n sus sult cep if d tib evic le m e c ate onta ria ins l T Produces technical file SE Drug CA/EMA Employs Notified Body Consultation if device contains medicinal substance ntains ice co es v tiv t if de onsul ood deriva C bl stable 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 Presentation title Name Placed on the EU market Post Market Surveillance inc Defined Adverse Events Reported Slide 3 Date © Crown copyright 2005
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 Presentation title Name Slide 4 Date © Crown copyright 2005
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 Presentation title Name Slide 5 Date © Crown copyright 2005
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 Presentation title Name Slide 6 Date © Crown copyright 2005
Safeguarding public health What is the need for guidance on reporting? Vigilance and user reporting Based on MEDDEV 12 -1 rev 6 vigilance guidelines Presentation title Name Slide 7 Date © Crown copyright 2005
Safeguarding public health Thank you Any Questions? Presentation title Name Slide 8 Date © Crown copyright 2005
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