1. Nicole Denjoy COCIR Secretary General
COM/CAMD Stakeholder Meeting on the new MD & IVD Regulations Thursday 09 March 2017, 11:10-11:30 Industry Implementation Priorities & Challenges
Nicole Denjoy
COCIR Secretary General

2. COCIR Implementation Priorities
Table of contents
COCIR Implementation Priorities
Gap Analysis on clusters & COCIR Challenges
Other General Concerns not covered by proposed clusters
Conclusions

3. 1. COCIR MDR Implementing Priorities
Clinical Evaluation
Post Market Surveillance & Vigilance
UDI/EUDAMED
Software
Standards

4. 1. Clinical Evaluation and Investigation
Common Specifications
Obligations to comply with CS ‘where these exist’ bring uncertainty on
If and when CS will be drafted and come into force for a particular product category
Applicability of CS to existing devices
Clarification and guidance needed on
‘State of the art’
‘Sufficient’ clinical data
Options to avoid unnecessary (unethical) clinical investigations
When randomized controlled trials will be required
Requirements for ‘contract between manufacturers’ to allow claiming equivalence to products of other manufacturers

5. 2. Post Market Surveillance & Vigilance
Shortened reporting timeline (Art. 87)
Multiple Reporting
New Post Market Surveillance report (Class I)
Periodic Safety Update Report (Class II and III)
New Technical PMS documentation (Annex IIa)
Post Market Clinical Follow Up during device life time
Roles and responsibilities of economic operators
Clarification definitions and terms
Guidance on PMS System & PMS Plan

6. 3. UDI/EUDAMED
Analyze the differences between MDR and FDA requirements (UDI)
Review Resource and cost association EUDAMED/UDI
Clarify the contents of basic UDI-DI, relationship with configurable device UDI-DI and impact on product structure
Develop guidance on roles and responsibilities for UDI System of economic operators
Clarify timeline for manufacturer registration in UDI/EUDAMED

7. 4. Software
Software classification changes significantly and will lead to a major up-classification of software, with major impact for SMEs.
App stores will be considered as economic operators
Further investigation will be done on impact of:
Classification of software (Rule 11)
Software safety requirements (GSPR 11.2 & 14.3)

8. 5. Standards Medical Devices are in need of:
Comprehensive set of standards listed in the OJEU giving Presumption of Conformity to some ERs
Timely Adoption of the latest standards (state-of-art)
Annexes Z to be written in practicable high-level language

9. 2. Gap Analysis based on EC/MS cluster approach & COCIR Identified Challenges

10. 0. Overarching & Cross-cutting priorities
Supporting needs for:
Resourcing and training – however, communication plan missing with central website etc
Ensure Eudamed fit for purpose and on-time (coordination?)
Stakeholder engagement & governance need clarification
MDCG establishment
Periodicity of meetings
Ways to engage
Ways to engage on clusters and mapping with existing groups (medical software borderline and classification, …)
Transition
3 years? 7 years for standards?....
Communication and awareness building will be critical
Not mentionned: Interaction with other Regulations
GDPR, Euratom BSS, mHealth quality Assessment guidelines, RED directive ….

11. 1. Scope and Classification
Concerns on plans to have so much references to Common Specifications
How to make sure redundancies are avoided?
Potential Barriers to Trade…
How to ensure proper use of standards?
Who will be in charge? Need a transparent mechanism in place, criteria and justifications as well as stakeholder engagement
Role of Guidance vs CSs vs standards?
Mapping with existing MEDDEVs?

12. How to ensure consistency with efforts developped at IMDRF level?
3. UDI
How to ensure consistency with efforts developped at IMDRF level?
Need clear plan and roles and responsibilities with targets
Reference to a global nomenclature? GMDN?
Convergence with US FDA and others and interoperability with national databases?

13. 4. Notified Bodies
Doubts on capacity in transition period and when full implementation of MDR
Need more transparency on NBs denotified/accredited – interlink with cross-cutting priorities?

14. 5. Clinical Evaluation & Clinical investigation
Reference to international standards and guidance (IMDRF) lacking
Links between ’Guidance’ and MEDDEVs?
Alarming references to CSs….

15. 6. Post-Market Surveillance @ Vigilance
Vigilance reporting:
Reporting channels between economic operators to be clarified
15 day reporting timelines: will have consequences in terms of # of reports / uncomplete information… unless clarification is given on when clock starts….

16. Lacking links with field reality….
7. Market Surveillance
Lacking communication between authorities in Europe and outside Europe (link with IMDRF NCAR system?)
Lacking links with field reality….

17. Other General Concerns – Missing elements
Need Communication Plans and centralised tools
Reference to New Approach and use of standards by competent authorities and NBs
No specific cluster on auditing plans and QMS and interlinks with MDSAP – part of cross-cutting priorities?

18. Need better understanding on how stakeholders can effectively engage
Summary-Conclusions
Need overall timelines and links with secondary legislation and ways it will be orchestrated
Need better understanding on how stakeholders can effectively engage
Lacking references to international standards
Proliferation of CSs will increase barriers to trade…