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Medical Device Revisions: Navigating Challenges and Opportunities in Regulatory Evolution

This case study by Phil Brown, presented on September 20, 2012, explores the evolutionary changes in the regulatory landscape surrounding general and active implantable medical devices. It covers recent updates prompted by the Medical Device Directive (MDD), incidents like the PIP and MoM issues, and the need for enhanced post-market surveillance. Key topics include the influence of notified bodies, auditing practices, and shifts in pre-market and post-market requirements. The study emphasizes the importance of transparency, risk mitigation, and adapting to evolving patient safety standards.

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Medical Device Revisions: Navigating Challenges and Opportunities in Regulatory Evolution

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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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