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 10 th 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; 1.Pre-Market requirements 2.Post-Market requirements 3.Labelling 4.Distribution channels 5.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