Medical Device Revisions
Case StudyPhil Brown20th September 2012
Medical Device Revisions
Case Study: Working with the Revision for General and Active Implantable Medical
Devices
Phil Brown10th 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 requirements2. Post-Market requirements3. Labelling4. Distribution channels5. 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?
