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

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

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

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

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

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

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)

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

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

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 ….

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?

How to ensure consistency with efforts developped at IMDRF level? 3. Eudamed @ 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?

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?

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

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….

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….

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?

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…