Скачать презентацию Safeguarding public health The regulation of IVF media Скачать презентацию Safeguarding public health The regulation of IVF media

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Safeguarding public health The regulation of IVF media Name: Dr Rosalind Polley Date: 2 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 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 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 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 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 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 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 © Safeguarding public health Thank you Any Questions? Presentation title Name Slide 8 Date © Crown copyright 2005

© Crown Copyright 2011 The materials featured within these MHRA presentation notes and delegate © Crown Copyright 2011 The materials featured within these MHRA presentation notes and delegate pack are subject to Crown copyright protection for this event. Any other copy or use of Crown copyright materials featured in this presentation, in any form or medium, is subject to prior approval of the MHRA which has Delegated Authority from Her Majesty's Stationery Office (HMSO) to administer Crown Copyright for MHRA originated material. Applications should be in writing, clearly stating the proposed use/reuse of the information, and should be sent to the MHRA at the following address: MHRA Corporate Communications and Marketing, 151 Buckingham Palace Road, London SW 1 W 9 SZ or e-mail: conferences@mhra. gsi. gov. uk. You may not sell or resell any information reproduced to any third party without prior agreement. The permission to reproduce Crown copyright protected material does not extend to any material in this pack which is subject to a separate licence or is the copyright of a third party. Authorisation to reproduce such material must be obtained from the copyright holders concerned. Presentation title Name Slide 9 Date © Crown copyright 2005