EUCOMED
HEALTH GOVERNANCE , 19th April 2012
Dario Pirovano Consultant Regulatory Affairs - Eucomed
A diverse sector
2
An exciting future
Patch with Cells
Drug device
combinations
Miniaturization
Next generation
imaging
Implantable electronics
Medical
Devices
Harvester
/Collector
Technology convergence
and smart devices
Mincer
Molecular and cellular
diagnostics
Kidney
Reconstruction
New biomaterials
(incl. biosurgicals)
Contact lens with chip
Cartilage
Repair
3
Comparison with Pharmaceuticals
 Pharmaceuticals
 Industry with longer history
 Primarily large multinationals
 Medical Devices
 Relatively young industry
 80% are small- and mediumsized companies
4
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
5
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
6
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
7
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
8
EU Regulatory Framework for Medical Devices
Last update 10 April 2012
CLASSIFICATION OF MEDICAL DEVICES (MD):
Manufacturer determines the CLASSIFICATION of his MD based on Annex IX of MDD and related guidelines (Meddev)
PRE-market
Class I (low risk)
Class IIa (low/medium risk)
Class IIb (medium/high risk)
Class III (high risk)
CONFORMITY ASSESSMENT PROCEDURE (ART. 11):
’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).
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.)
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)
Manufacturer’s self-assessment
of his device 1
DECLARATION OF CONFORMITY AND CE MARKING:
POST-market
Manufacturer issues a declaration of conformity stating that each device is in compliance with the all applicable Directives and affixes the CE marking
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)
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)
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)
VIGILANCE SYSTEM (in case of incidents):
1 For
devices with measuring function or which are sold sterile there is an intervention from the Notified Body
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
10
6 steps to a smarter legal framework for medical devices:
2
1
One approach to
vigilance and
market
surveillance
Only the best
Notified Bodies
4
3
5
Consistent
implementation
of guidelines
Strengthened
harmonized
standards
6
Increased
transparency
An integrated
approach: Better
coordination and
management
October 2011: Eucomed favours JRC
Coordinating Committee of Member States
with Administrative Support from:
Option 1
Oversight by Member States
Option 2
Assistance of DG Research’s Joint Research Centre and/or DG
SANCO’s Executive Agency for Health and Consumers
Option 3
Option 4
Standalone Agency
Directorate in EMA
= Commission
= Member States (Heads of Agency approach)
= Agency
12
Expected timeline for the MDD revision
EU
Presidencies
Commission: Public consultation /
Impact Assessment
08/2008
DK, CY
Commission: Legislative Proposal
Q2/2012
08/2011
IE, LT
Parliament and Council: First reading
EL, IT
LV, LU
NL, SK
June 2014
EP
Elections
2014/15
Parliament and Council: Second reading
(and Conciliation)
National and local authorities:
Implementation
Commission and Court of Justice:
Surveillance / enforcement
2017/18
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
Eucomed Secretariat Organisational Chart
Luciano Cattani
Chief Executive
Florence Poncin
Senior Manager
HR & Administration
Sonja Kropidlowska
All-round Assistant
John Brennan
Director
Regulatory & Technical Affairs
Merlin Rietschel
Manager
Regulatory & Technical Affairs
Dario Pirovano
Consultant
Regulatory Affairs
Andy Vaughan
Consultant
Environnement
(Part-time)
Thecla Sterk
Regulatory Affairs
Officer
In Interim (as of January 2012)
Rubie Santos
Admin. Assistant
Tanja Valentin
Senior Manager
Public Affairs
Valentina Ancona
Public Affairs Officer
Yves Verboven
Consultant EHTI
VACANT
Director
Economic Affairs
Ingmar de Gooijer
Director
Communications
Cristian Manoiu
Manager Economic
Affairs – Data Analyst
Petra Grigorovova
Data Analyst
Jelena Merkurjeva
Data Analyst
Christopher Breyel
Manager Membership
Services & Events
Aline Lautenberg
Senior Legal
Counsel
Kristina Smailyte
Junior Legal Officer
Laurence Couturier
Communication & Events
Officer
Zuzana Fikarova
Economic Affairs Officer
Thomas Lindemans
Senior Communications
Officer
Sophie Koettlitz
Economic Affairs Officer
– EHTI (Part-time)
Brett Kobie
Communications Officer
15
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, 2009
Europe refers to EU-27 plus Norway and Switzerland
17
Global Healthcare Expenditure
The total Global healthcare expenditure accounts for 5.7 trillion US$ in 2009*
18
Total Healthcare vs. Medical Device Expenditure, Europe
Source: Espicom, World Bank, Eucomed calculations, 2009
*IVD are not included
19
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.
20
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
21
Ambition
 Be a center of competency for policymakers;
 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.
2.
3.
4.
Determine the optimum scenario
Align future position of the industry
Define action plan of Eucomed / NA
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!
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