Annual Medical Devices Symposium 2015 Session 1: The new EU Device Regulations

Impact on industry

Tuesday 13 October 2015, Berlin

Nicole Denjoy

COCIR Secretary General

Table of Contents

1. Introducing COCIR

2. European regulatory framework: Industry priorities

3. Sharing long term competence in medical device regulatory framework

4. Critical Analysis: COCIR views

1. Introducing COCIR

Industry sectors covered by COCIR

COCIR covers 4 key industry sectors: • Medical Imaging • Radiotherapy • Electromedical • Health ICT

Our Industry leads in state-of-art advanced technology and provides integrated

solutions covering the complete care cycle

COCIR is a non-profit trade association, founded in 1959 and having offices in Brussels and China, representing the medical technology

industry in Europe

Central Patient’s

EHR

Home

Pharmacy

Laboratory

Polyclinic Hospital

Government

COCIR’s Focus: improve market access

• Provide COCIR’s members with competence towards policy makers in Europe and outside

• Contribute to sustainability of healthcare systems through integrated care approach

• Promote Research and Innovation as a key enabler for economic growth

• Drive global regulatory convergence (registered once, accepted everywhere)

• Optimise use of International standards

• Push for national and regional deployment (eHealth)

• Pro-active in Green Technology (Eco-Design)

33 COCIR Company Members

14 COCIR National Trade Associations Members

COCIR at international level

2015: DITTA was granted a NGO status with WHO 2014: DITTA has official liaison with AHWP

2. European regulatory framework:

Industry priorities

What is important?

The protection and the well-being of patients remains of the highest importance

The growth, jobs and competitive European industry is also crucial

•Current system

1. Implementing the current system

2. Keep what is working well

3. Better enforce existing rules

•Future regulation

1. Regulation versus Directive

2. What is needed?

3. Eliminate known weaknesses

4. Improve transparency and predictability

Evolution rather than Revolution

Current System 1/3

Implementing the current system

• Boost the ‘Joint Immediate Action Plan’:

– Functioning of Notified Bodies

– Market Surveillance and Vigilance

– Unique Device Identification

• Importance of Coordinated Implementation amongst Member States

• Better use of Information and Communication Technology (e.g. product registration and post market surveillance)

Current System 2/3 Keep what is working well

• Maintain the risk-based system for classification of medical devices

• Maintain the “New Approach”:

– Performing Conformity Assessment Procedures • Under risk-based involvement of Notified Bodies

• Under the supervision of Competent Authorities

• Based on risk management and quality management system

• Based on harmonized standards and clinical data

• Under the primary responsibility of manufacturers regarding the CE marking

– Fast availability of innovative medical devices • Early patient benefit

• Strengthening the competitiveness of European medical device manufacturers

Current system 3/3 Better Enforce Existing Rules

• Strengthen market surveillance and vigilance systems:

– Enforced surveillance by competent authorities of Member States

– Better use of the instrument to perform unscheduled controls

– Better enforcement of reporting requirements for adverse events

• Strictly enforcing the existing sanctions in the case of violations

• It will ensure the new regime is interpreted and applied consistently throughout all Member States.

• The new regulatory structure should remain robust, transparent and adaptable to scientific and technological progress.

• The over-riding objective must be for smart and efficient regulation delivering patient safety, high quality and rapid access to highly-innovative medical technology.

Medical Device Regulation 1/4 Regulation versus Directive

Medical Device Regulation 2/4 What is needed in such regulation?

• Coordination and cooperation of Authorities on Notified bodies, Vigilance and Market Surveillance

• Certainty on EU and International Standards and Guidelines for Patient and Consumer Safety

• Transparency and Involvement of Stakeholder Advisory Group (Industry, Patients, Scientific Societies)

• Traceability; Unique Device Identification, UDI (Globally coherent)

• Enhanced use of Information and Communication Technology, ICT to connect the system and monitor post market performance (vigilance, registries, etc.)

Medical Device Regulation 3/4 Eliminate known weaknesses

• Coordination and cooperation between competent authorities of Member States

– Exchange of data between authorities: Establishing a common database for registration of manufacturers, certificates, products, clinical trials and market surveillance data

– Alignment of vigilance systems

– Harmonized notification and surveillance of Notified Bodies

• Improve and align the functioning of Notified Bodies

– Harmonized and higher quality level of Notified Bodies

– Better expertise of Notified Bodies

– Harmonized and stronger surveillance of Notified Bodies

• Strengthening the Notified Bodies

– Clear assignment of tasks, e.g. mandatory unannounced audits

Medical Device Regulation 4/4 Improve Transparency and Predictability

• Transparent processes • Clear responsibilities of all stakeholders:

– Competent Authorities – Manufacturers – User (maintenance,…) – Healthcare provider (IT network, integrated/combined solutions, …) – Distributors/importers (ref to traceability, …)

Safety is a shared responsibility!

• Unambiguous, predictable and binding rules

– Especially important for SMEs – Legal certainty regarding applicable standards and guidelines – Direct participation of all relevant stakeholders (authorities, Notified

Bodies, industry, users, patients, academia, …)

The Key Priorities for Industries

Common work to support the system’s safety and innovation elements:

Best practices in:

• Vigilance

• Clinical

• Standards

Implementation of:

• A sustainable regulatory model

• Unique Device identification, UDI

• Information and Communication Technology, ICT

3. Sharing long standing competence in Medical

Devices Regulatory Framework

Legislative Process Overview

• 08 May 2008: European Commission public consultation

• 09 February 2012: European Commission adopts Joint Plan for Immediate Actions under existing Medical Devices Legislation (following PIP breast implants scandal)

• 26 September 2012: European Commission adoption of regulation proposal

• 02 April 2014: European Parliament amendments

• 05 October 2015: Council of the European Union General Approach

• 13 October 2015: First Trilogue meeting between European Commission, European Parliament and Council of the European Union

• June 2016 (best case): Final MDR adoption by EU Institutions

and after publication 3 years transition period (June 2019)

COCIR Activities in MDR

• COCIR developed key documents constantly revised to express industry recommendations towards policy-makers and stakeholders:

• COCIR High Level Contribution on the Proposal for Medical Devices Regulation (13 recommendations) – Publicly available

• Additional Technical Documents:

Software as a Medical Device

Vigilance

Harmonised standards & Common Specifications

COCIR Key Topics

1. Vigilance

2. Software (as a Medical Device)

3. Harmonised standards and Common Specifications

4. Chemicals

5. Transparency 6. Scope and definitions 7.Delegated acts 8. Transition period 9. Scrutiny procedure 10. Unique Device Identification 11.Economic operators 12.Clinical data and investigations 13. Reprocessing

COCIR High Level Contribution (4 top issues)

1. Post-market

• Issue(s): • Reporting of ‘Serious’ incidents vs. incidents (European Parliament amendment)

• Reporting time frame (30 days or 15 days)

• Post-market surveillance system

• Economic operators

• COCIR recommendation(s): • Keep the scope limited to ‘serious’ incidents

• Ensure clarity and consistency of reporting time frame (e.g. 15 days after becoming aware of the incident is too short)

• Introduce a tailored post-market surveillance system taking into account the medical device’s life cycle

• Clear obligations must be defined for economic operators (e.g. AR, Importers)

2. Software

• Issue(s):

• Removal of sentence: ‘Stand alone software shall be considered an active device’ (Council of the European Union General Approach)

Now only one classification rule applies to software (Rule 1)

• Using the rules for active devices as defined by the current Medical Devices Directive (Rules 9-12) does not provide a solution

• COCIR recommendation(s):

• Ensure software can be classified commensurate with the risk it possesses by ensuring clarity and international convergence

3. Reference to Standards

• Issue(s):

• ‘Common Specifications (CS) for all’ approach

• COCIR recommendation(s):

• Maintain the central role of harmonised standards as per current New Approach

• Use CS only in exceptional cases, ensuring input by all stakeholders

4. Chemicals

• Issue(s):

• The European Parliament’s amendment on the management of hazardous substances

• COCIR recommendation(s):

• Maintain the European Commission’s proposal on the management of hazardous substances

• Refer to already existing Environmental legislation (RoHS, WEEE, REACH)

4. Critical Analysis – COCIR Views

Critical Analysis – COCIR Views

Topic (+) (-)Increase of Requirements

Increase on Controls (NBs, industries, …)

Integration of various parts incl. Elements

of some guidances

Decrease variability between countries

Central Portal

Medical Software Towards IMDRF BUT Classifiation Rules not appropriate

BUT need to limit to 'serious'

15-30 days notification - still need resolution

Standards New Approach kept - Need to keep

harmonized standards publication

BUT CSs

UDI Single EU system planned BUT need convergence with IMDRF

Economic Operators Better defined (distributor, importer, AR,

…)

BUT still need clarifications and avoid

redundancies (importer vs AR)

Clinical data and

investigations

Multicentric approach simplified - More

harmonisation

More details required from CI promotor BUT

process too Pharma oriented

Reprocessing Covered BUT deviations may affect patient safety

Regulation In General BUT Delegated Acts: potential increase of

uncertainty/unpredictability (exclude

delegated acts for ERs)

NotificationIncidents

In Summary:

• Towards more harmonisation

• Better interface between Member States

• Increase NB competences

• More controls

• More administrative burden

Important to restaure confidence in CE Marking Process

Back-Up slides

COCIR High Level Contribution

(9 additional points)

• 5. Transparency

• Define ‘appropriate access levels for public’ and ‘appropriate access levels for healthcare professionals’

• Support European Parliament amendment concerning the creation of a Medical Device Advisory Committee (MDAC)

• 6. Scope and definitions

• Reject European Parliament amendment concerning the definition of ‘medical device’ (to include devices with ‘indirect’ medical purposes)

• Clarify the Council of the European Union General Approach term ‘clinical benefit’

• Define the Council of the European Union General Approach term ‘patient management’

• 7. Delegated Acts

• Maintain legal certainty by limiting the use of Delegated Acts to cases where they are genuinely needed

• Support European Parliament Amendment concerning avoiding modifications of the General Safety and Performance Requirements, the technical documentation rules and the conformity assessment procedures via Delegated Acts

• 8. Transition period

• 3 years can only suffice if manufacturers can make meaningful preparations throughout this period, starting from the availability of the implementing legislation

• 9. Scrutiny procedure

• Strengthen the performance of Notified Bodies

• Minimise and advance any special review of high risk medical devices, where truly needed for patient safety

• Reject European Parliament amendment concerning the creation of a new category of Notified Bodies

• Replace the process for clinical evaluation consultation by analogous provisions in Council of the European Union’s General Approach on proposal for a Regulation on in vitro diagnostic medical devices

• 10. Unique Device Identification

• Support a single European system and database that is aligned with the United States’ FDA Final Rule

• Support European Parliament amendment concerning European UDI

• 11. Economic operators

• Clarify the various roles and responsibilities and avoid overlaps (e.g. importer versus Authorised Representative)

• Reject European Parliament’s amendment and Council of the European Union’s General Approach for the words ‘medical device’ to accompany the CE marking

• 12. Clinical data and investigations

• Tailor the system to the unique characteristics of medical devices and avoid borrowing from the pharmaceutical model

• Concerns for both Council of the European Union General Approach and European Parliament Amendment

• 13. Reprocessing

• Ensure a high level of patient safety by extending all manufacturer obligations and liabilities to reprocessors of single-use medical devices

• Reject Council of the European Union General Approach concerning allowing reprocessing where permitted by national law