1. Upcoming changes in EU medical device regulation
The future of MedTech innovation in Europe at stake
HealthTech Summit, 26 June 2013, London

2. www.dontlosethe3.eu
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3. How does Europe work?
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4. What industry wants to achieve
Industry wants a clear, predictable and effective
regulatory system specifically tailored for medical devices
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1. SAFETY
2. TIMELY ACCESS
3. TRUST
4. SUSTAINABILITY
5. INNOVATION

5. What industry proposes
Improve decentralised device-specific approval system
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1. NOTIFIED BODIES
2. ENFORCEMENT
3. CLINICAL REQUIREMENTS
NO PMA

6. Where are we today?
1. European Commission has “scrutiny” in proposal
2. European Parliament has centralised PMA system in
draft report
 But more than 700 amendments
 Vote on 10 July (plenary in September)
3. EU Council position and timeline unclear
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7. Maintain investment & innovation in Europe
Europe needs an approval system that ensures
1. High safety
2. Timely market access
3. Predictability
4. Reasonable approval costs
5. Incentives to innovate
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Improved
Decentralised
Approval
System

8. What will the future look like?
Best case:
 Improved decentralised approval system
 Continuous timely innovation cycles
 Supportive of SMEs, startups
Worst case:
 Slow, bureaucratic centralised approval system
 Lengthy, unpredictable approval delays
 Detrimental to small innovators
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