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? Revisions as a result of MDD update Revisions as a result of PIP / MoM issues Impacts Challenges and mitigation steps Opportunities

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?

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?

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

Medical Device Revisions Five main areas of change; 1.Pre-Market requirements 2.Post-Market requirements 3.Labelling 4.Distribution channels 5.Costs

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

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?

Medical Device Revisions Labelling – Consideration of UDI – Third Party information

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

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?

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?

Medical Device Revisions Phil Brown