Industry Implementation Priorities & Challenges COM/CAMD Stakeholders meeting on the new MD and IVD Regulations 9 March, 2017 John Brennan Director Regulations & Industrial Policy MedTech Europe

1. Overall Gap Analysis 2. Specific: In vitro Diagnostic Medical Devices 3. Specific: Medical Devices 4. Common Issues IVDR/MDR 5. Showstoppers IVDR/MDR

Overall Gap Analysis

Overall: IVDR is the gap Either remain strategic on both (deleting the MD detail) or add equivalent detail on IVD Document is strategic on IVD but detailed on MD (e.g. clusters 1 & 5) We recommend to add equivalent detail on IVD IVD Regulation = major overhaul for sector: all devices newly classified, ~85% newly move to a new notified body system and new requirements for clinical evidence Recognise workload and investment needed to make IVDR implementation work

Specific: In vitro Diagnostic Medical Devices

Gap analysis: Cluster #2, IVD Specific Issues Keep all points and add: Guidance on Classification Legacy products Timelines/process to update, resolution of issues, process for binding decisions? Clinical Evidence What are the different expectations across the different classes and types of devices Performance evaluation Give specific detail for IVDs, equivalent to detail given for MDs Notified body issues Designation – specific approach needed Conformity assessment Process: specify for class and types Common Specifications for class D Guidance on Technical documentation expectations

Specific: Medical Devices

Gap analysis: Clusters #1 & #5, MD Specific issues #1. Scope & Classification Guidance on new consultations with other Authorities regarding “Rule 18” Role of EMA regarding “Rule 21” products #5. Clinical Evaluation & Clinical Investigation Guidance/approach for existing devices (so-called legacy aspect) Expectations for ‘new’ & ‘iterative’ devices

Common issues IVDR/MDR

Gap analysis - Is anything missing? Overall document: IVD (as stated before) Overall clarity on the new governance of the system including new entities, structures and inclusive consultation processes Further specify what is needed to address priority work Not only Guidance - also Implementing acts, Commission decisions, tri-fold brochures, etc. Some (broad) timelines are necessary Governance and process for early stakeholder engagement, especially, for example, in Common Specifications where expert advice from all stakeholders is needed at the early phase

Gap analysis - Is anything missing? Clusters: 0. Overarching & Cross-cutting priorities Transitional provisions and derogations: Vigilance on feasibility of all to meet timelines (be ready to act) Clarity on all provisions Communication/info to all (EU & International) e.g. downloadable tri-fold brochure Governance and Process for Stakeholder engagement Resourcing & training requirements Accessible training & info for all Standards Process to smoothly support transition to IVDR/MDR Ensuring that rules on General Data Protection and Intellectual Property (IP) & ‘Know-how’ protection are respected

Gap analysis - Is anything missing? 3. Eudamed & UDI Eudamed Admin/Management of Eudamed (e.g. account set-up, user roles, data maintenance etc.) UDI data Consistency with international standards and guidance Guidance on definition, scope of 'Basic UDI-DI' How & when to assign & use UDI, including in documentation Tech specs for data elements Tech specs for data exchange UDI marking/carrier How to apply and manage exceptions Appropriate GMDN system for IVD Currently there is 1 GMDN code for every 2 IVDs. This is too detailed for regulatory purposes.

Gap analysis - Is anything missing? 4. Notified bodies Notified Body Operational Group (NBOG) codes Mention of the ‘fit-for-purpose’ IVD specific NBOG code approach being generated to support IVDR Contingencies within designation process E.g. After date of application, what happens to products covered by Directives in the event that the notified body ceases its activities? 6. PMS & Vigilance Vigilance reporting Guidance, including coding of events Trend, signal detection, signal management

Gap analysis - Is anything missing? 7. Market surveillance Role and overall plan for adaptation of the MEDDEVs to the Regulations How to upgrade the Classification and Borderline Manual

Showstoppers: IVDR/MDR

IVD Regulation Classification Performance evaluation (interim) Guidance needed Performance evaluation (interim) Guidance needed including on terms, legacy products etc. Templates for performance evaluation report, post-market performance follow- up evaluation report, summary of safety & performance Conformity assessment Implementing act for class B and C Common Specifications for class D Notified bodies under IVDR Timely availability, able to cover x8 increase in notified body workload with >85% of IVDs needing notified body oversight for first time EUDAMED Fully operational & intuitive to use Vigilance system Implementing acts Overall clarity on the new governance of the system

MD Regulation Transition Notified bodies Clinical requirements EUDAMED Clarity on provisions & derogations Feasibility of all to meet timelines Notified bodies Timely availability Capacity Clinical requirements Guidance on existing devices (so-called legacy aspect) Overall Guidance on clinical evaluation Expectations for ‘new’ & ‘iterative’ devices EUDAMED Management of Eudamed UDI Guidance on definition, scope of 'Basic UDI-DI‘ How & when to assign & use UDI, including in documentation Consistency with international standards and guidance UDI marking/carrier Overall clarity on the new governance of the system