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Medical Device Revisions Case Study

Medical Device Revisions Case Study. Phil Brown 20th September 2012. Medical Device Revisions. Case Study: Working with the Revision for General and Active Implantable Medical Devices Phil Brown 10 th September 2012. Medical Device Revisions. Evolution rather than Revolution?

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Medical Device Revisions Case Study

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  1. Medical Device Revisions Case Study Phil Brown 20th September 2012

  2. Medical Device Revisions Case Study: Working with the Revision for General and Active Implantable Medical Devices Phil Brown 10th September 2012

  3. Medical Device Revisions Evolution rather than Revolution? • Revisions as a result of MDD update • Revisions as a result of PIP / MoM issues • Impacts • Challenges and mitigation steps • Opportunities

  4. Medical Device Revisions • MDD Update • Transparency (awareness of products and process) • Centralization? • Commission to scrutinize NB Class III assessments, Pre-Market Approval? • Reprocessing of ‘Single Use Devices’ • Designation and Supervision of Notified Bodies • More emphasis on Post Marketing Surveillance • Control over Economic Operators • UDI • Qualified Persons?

  5. Medical Device Revisions • ‘PIP’ / MoM Update • To reinforce greater post market surveillance • Adverse Event Reporting • Potential use of Registries • Audit of PMS plans / formalise PMS structures • Focus on NB audits • Competent Authority scrutiny of NBs • Company scrutiny by NBs • Unannounced auditing by NBs • UK Lead?

  6. Medical Device Revisions Consider the impact on the manufacturer and how to work with the (proposed) ‘Revisions’

  7. Medical Device Revisions Five main areas of change; • Pre-Market requirements • Post-Market requirements • Labelling • Distribution channels • Costs

  8. Medical Device Revisions Pre-Market Requirements • Technical Requirement change? • Increased Notified Body influence? • More Conformity Assessment scrutiny • Innovation • Commission Scrutiny / PMA? • Time to market

  9. Medical Device Revisions Post-Market Requirements • Post Marketing Surveillance improvements • Registries • Audits, planned and un-announced • Greater integration of QA and RA • Qualified Person responsibilities • Third Party Reprocessing of products?

  10. Medical Device Revisions Labelling • Consideration of UDI • Third Party information

  11. Medical Device Revisions Distribution channels • More control over Third Parties • More Third Party scrutiny • Legal input into contracts • Auditing - integration of QA/RA functions • Third Party responsibilities

  12. Medical Device Revisions Costs • Relating to Post Marketing Surveillance • Auditing and control of Third Parties • Notified Body costs • UDI / labelling • Class III costs for scrutiny • Re processing issues?

  13. Medical Device Revisions Conclusions • Fundamental ‘New Approach’ principles remain • Aimed at boosting patient and end-user confidence • MDD in need of modernising • Anticipating next 10/15 years • To lead to increased costs? • Slow progress to more Pharma style regulation?

  14. Medical Device Revisions Phil Brown phil.brown25@btinternet.com 07810 484025

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