Upcoming changes in EU medical device regulation

The future of MedTech innovation in Europe at stake

HealthTech Summit, 26 June 2013, London

www.dontlosethe3.eu

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How does Europe work?

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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

What industry proposes

Improve decentralised device-specific approval system

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1. NOTIFIED BODIES

2. ENFORCEMENT

3. CLINICAL REQUIREMENTS

NO PMA

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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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

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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