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

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

3. Overall Gap Analysis

4. 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

5. Specific: In vitro Diagnostic Medical Devices

6. 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

7. Specific: Medical Devices

8. 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

9. Common issues IVDR/MDR

10. 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

11. 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

12. 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.

13. 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

14. 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

15. Showstoppers: IVDR/MDR

16. 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

17. 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