EUCOMEDHEALTH GOVERNANCE , 19th April 2012Dario Pirovano Consultant Regulatory Affairs - Eucomed

2

A diverse sector

3

Medical Devices

Patch with Cells

Cartilage Repair

KidneyReconstruction

MincerHarvester/Collector

New biomaterials (incl. biosurgicals)

Implantable electronics

Miniaturization

Contact lens with chip

Technology convergence and smart devices

Molecular and cellulardiagnostics

Next generation imagingDrug device

combinations

An exciting future

4

Comparison with Pharmaceuticals

Pharmaceuticals Industry with longer history Primarily large multinationals

Medical Devices Relatively young industry 80% are small- and medium-

sized companies

5

Comparison with Pharmaceuticals

Pharmaceuticals Limited number of products Development by trial and selection on

the basis of quality, safety and efficacy Therapeutic Based on pharmacology, chemistry,

biotechnology, and genetic engineering Biologically active and effective when

absorbed by the body

Medical Devices More than 10,000 products (different

sizes, models, etc.) Designed specifically to perform

certain functions based on quality, safety and performance

Diagnostic, therapeutic, monitoring Based on mechanical, electrical

and/or materials engineering Generally act by physical means

6

Comparison with Pharmaceuticals

Pharmaceuticals Continuous innovation and some

improvements based on new science and technology

Innovation primarily the result of laboratory work

Extensive product lifetime and long investment recovery period

“Breakthrough drugs”

Medical Devices Continuous innovation and iterative

improvements based on new science, technology and available materials

Innovation primarily the result of insights from clinicians

Short product lifetime and investment recovery period (~18 months)

New devices bring added functions and clinical value based on incremental improvements

7

Comparison with Pharmaceuticals

Pharmaceuticals Low distribution cost No service or maintenance Limited training required

(compared to high-tech medical devices)

Medical Devices High cost of distribution Training and education essential High cost of training and

education Extensive service requirements

8

Comparison with Pharmaceuticals

Pharmaceuticals Randomized control trials are

‘gold standard’ Efficacy and efficiency can be

largely demonstrated prior to market

Drugs either work or don’t work: efficacy and efficiency easy to demonstrate

Medical Devices Randomized control trials not

always scientifically informative or possible and hence not ‘gold standard’

Efficacy and efficiency can be only truly be demonstrated through actual use and uptake in the market

Medical devices are part of whole system and their efficacy relies on the skills and experience of the physician, the quality of the hospital, and other factors

EU Regulatory Framework for Medical Devices

VIGILANCE SYSTEM (in case of incidents): a) Manufacturer is obliged to REPORT any incident related to his devices to the Competent Authority (Article10 and Annex II, paragraph 3.1)

b) A Member State may decide to WITHDRAW, RESTRICT or PROHIBIT the marketing of the device (Safeguard Clause, Art. 8)

PR

E-m

arke

tP

OS

T-m

arke

t

CLASSIFICATION OF MEDICAL DEVICES (MD): Manufacturer determines the CLASSIFICATION of his MD based on Annex IX of MDD and related guidelines (Meddev)

Class I (low risk) Class IIb (medium/high risk) Class III (high risk)Class IIa (low/medium risk)

CONFORMITY ASSESSMENT PROCEDURE (ART. 11):

DECLARATION OF CONFORMITY AND CE MARKING: Manufacturer issues a declaration of conformity stating that each device is in compliance with the all applicable Directives and affixes the CE marking

Manufacturer’s self-assessment of his device 1

1 For devices with measuring function or which are sold sterile there is an intervention from the Notified Body

Manufacturer must keep TD and QAS updated and adapt according to all gained post-market experience . NB regularly audits both, typically once per year (Annex II, paragraph 3.1)

Pre-market approval for class III: Manufacturer submits TD as a ‘Design dossier’ to the NB. NB assesses it and issues a ’Design-examination Certificate’ (Annex II or III)

POST- MARKET SURVEILLANCE (preventive):

a) The manufacturer must have a post-market surveillance system in place, as an integrated part of the ‘quality assurance system’ and audited by a NB, in order to collect, review and assess all information gained on a device in the post-market phase (Annex II, paragraph 3.1)

b) Competent Authorities are responsible to monitor all devices on the market , i.e. through audits, product samples, complaints (Article 2)

Last update 10 April 2012

Notified Body (NB) audit: NB assesses the TD and the QAS through an on-site inspection of the manufacturing premises, which takes 2-5 days. NB issues a Conformity Assessment ‘Certificate’ (Annex II 3.3. or Annex V 3.3.)

’Technical documentation’ (TD): to be created by the manufacturer. It demonstrates the safety and performance of the device by proving that all ‘Essential Requirements’ laid down in the MDD are met (Annex I) and includes a clinical evaluation (Annex X) and a risk assessment . All are based on clinical data.

‘Quality Assurance System’ (QAS): to be set up by the manufacturer. Ensures that each individual device fully meets the standards defined in the technical documentation. Achieved through clearly defined procedures for every step of the manufacturing process, from design phase to final inspection (Annex II or V).

10

Revision could sort out weaknesses of current system?

Lack of Transparency = Lack of trust in System Overly “confidential” system

Different expertise/performance of Notified Bodies

Perception that Authorities are divorced from the process, particularly for complex class III devices

Transparency of overall system, in particular no visibility of what’s on the market

Poor perception of system by those external to EU

Challenges to Innovation = Threat to patients’ choice Public Health Authority understanding of new technologies

Lack of Guidance including regulatory predictability and agreed clinical guidelines, in particular on innovative new technology

Fragmented Market = Threat to legal market access Multiple national registrations and overly bureaucratic processes

National ‘safeguard’ measures create multiple national requirements

Multiple national approaches to vigilance, borderline and classification

6 steps to a smarter legal framework for medical devices:

Only the best Notified Bodies

One approach to vigilance and

market surveillance

Strengthened harmonized standards

Consistent implementation

of guidelines

Increased transparency

An integrated approach: Better coordination and

management

1

4 5

2 3

6

12

October 2011: Eucomed favours JRC

Coordinating Committee of Member Stateswith Administrative Support from:

Oversight by Member States

Directorate in EMA

Standalone Agency

Option 1

Option 3

Option 4

= Commission

= Member States (Heads of Agency approach)

= Agency

Assistance of DG Research’s Joint Research Centre and/or DG SANCO’s Executive Agency for Health and Consumers

Option 2

Commission: Public consultation /

Impact Assessment

Commission: Legislative Proposal

Parliament and Council: First reading

Parliament and Council: Second reading

(and Conciliation)

National and local authorities: Implementation

Commission and Court of Justice:

Surveillance / enforcement

Expected timeline for the MDD revision

Q2/2012

08/2011

2014/15

2017/18

08/2008

DK, CY

IE, LT

EL, IT

LV, LU

EU Presidencies

NL, SK

June 2014EP

Elections

Why a European Trade Association?

The rules of the game are changing

Increasingly, policy-makers are staying

ahead of industry

What to do to stay engaged?

More frequent exchange of views and

updates on key policy dossiers are

vital

Early warning on evolving crises

Coordinate messages and timing on

advocacy on key issues

15

Eucomed Secretariat Organisational Chart

In Interim (as of J anuary 2012)

John Brennan Director

Regulatory & Technical Affairs

VACANT Director

Economic Affairs

Florence Poncin Senior Manager

HR & Administration

Luciano Cattani

Chief Executive

Sonja Kropidlowska All-round Assistant

Rubie Santos Admin. Assistant

Tanja Valentin Senior Manager

Public Affairs

Dario Pirovano Consultant

Regulatory Affairs

Thomas Lindemans Senior Communications

Officer

Brett Kobie Communications Officer

Sophie Koettlitz Economic Affairs Officer

– EHTI (Part-time)

Cristian Manoiu Manager Economic Affairs – Data Analyst

Thecla Sterk

Regulatory Affairs Officer

Andy Vaughan Consultant

Environnement (Part-time)

Petra Grigorovova Data Analyst

Christopher Breyel Manager Membership

Services & Events

Laurence Couturier Communication & Events

Officer

Ingmar de Gooijer Director

Communications

Aline Lautenberg Senior Legal

Counsel

Zuzana Fikarova Economic Affairs Officer

Merlin Rietschel Manager

Regulatory & Technical Affairs Valentina Ancona

Public Affairs Officer

Jelena Merkurjeva Data Analyst

Kristina Smailyte J unior Legal Officer

Yves Verboven Consultant EHTI

EUCOMED and Medical Technology Industry

Eucomed represents the medical technology industry in Europe. Our mission is to make modern,

innovative and reliable medical technology available to more people.

Based in Brussels, Belgium

24 staff

Members:

25 national industry associations

3 associate Members

58 direct corporate members

Medical technology industry in the EU

About 22,500 medical technology companies in EU

80% SMEs

95 billion EUR annual sales; 8% re-invested in EU

Nearly 500,000 employees

> 500,000 products (10,000 generic groups)

One new European patent every 38 minutes*

* OECD 2010; European Patent Office 2006

European MedTech Industry

Source: World Bank, EDMA, Espicom and Eucomed calculations, 2009Europe refers to EU-27 plus Norway and Switzerland

17

18

Global Healthcare Expenditure

The total Global healthcare expenditure accounts for 5.7 trillion US$ in 2009*

Total Healthcare vs. Medical Device Expenditure, Europe

Source: Espicom, World Bank, Eucomed calculations, 2009 *IVD are not included

19

20

Eucomed is active in the following spheres:

Economic affairs; including market data collection, health economics, funding and

reimbursement, health technology assessment and new trends (homecare)

Regulatory affairs; including vertical legislation (such as medical devices directives and

advanced products regulation), horizontal legislation (e.g. environmental) and standards

Science and innovation; including medical nanotechnology and other emerging technologies,

research and innovation projects

International affairs; including global regulatory harmonization (GHTF), relations with the US,

Japan, China and India

Ethics; including enforcement of the Eucomed Code of Business Practice

Public affairs; including outreach to and relations with the European institutions and the

Member States

Communications and external relations; including partnerships with patient groups and

medical associations, events, publications and media relations.

21

Main sector groups at Eucomed are:

1. Ophthalmic surgery & vision care

2. Orthopaedic

3. Cardiovascular

4. E-health

5. Patient Safety Groups

6. Community Care

7. Surgical care

Ambition

Be a center of competency for policy-

makers;

Show and demonstrate that the medical

technology industry offers innovative and

cost-effective solutions to improve patient

lives;

Engage healthcare influencers across

government, industry, patient advocacy,

healthcare professionals to work toward

consensus on health policy issues.

Strategic Actions

Short Term

1. Demonstrating the value proposition of the industry is critical

• Communications (Eucomed/NA)• Public Affairs Machine (Eucomed/NA)• Ethical Campaign (Eucomed/NA/ADV)• Data generation

2. Address threats and opportunities to address value

• Regulatory burden (MDD Revision) (Eucomed)• Reimbursement / Procurement / Late Payment (Eucomed/NA)• Shaping HTA Environment (Eucomed/NA)

Alignment of actions Eucomed and NA

Likely scenario to support all sectors

Mid Term of validations and trends/scenarios by key internal groups (NA, sector…)

1. Determine the optimum scenario2. Align future position of the industry3. Define action plan of Eucomed / NA4. Build value proposition thorough targeted stakeholders

• Patients• HCP• Governments• Payers

5. Monitor e-Health Development

React Influence Drive

Programme and registration at www.medtechforum.eu

Early bird rates: Save up to 20% by registering before 30 June!

GRAZIE PER L’ATTENZIONE