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Download The Key - Winter 2012 (PDF, 468KB) - Kennedys

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strengthening of the existing rules rather than a<br />

total overhaul.<br />

Concerns are already being raised within the<br />

industry that increased levels of scrutiny and<br />

monitoring will lead to delays in bringing new<br />

medical devices to the marketplace.<br />

It is essential to maintain the economic and<br />

commercial viability of products. Too much<br />

regulation can delay life-saving products coming<br />

to market and undermine research and<br />

development. <strong>The</strong> European Commission has<br />

acknowledged that the medical device and in<br />

vitro diagnostic medical devices sectors – which<br />

employ more than 500,000 people in about<br />

25,000 companies – are key drivers when it<br />

comes to European economic growth. This is<br />

especially important given that 80 percent of<br />

European medical device manufacturers are<br />

small to medium-sized companies (SMEs)<br />

<strong>The</strong> changes are designed to promote innovation<br />

by not overburdening manufacturers with<br />

complex and unworkable rules.<br />

What happens next?<br />

<strong>The</strong> new proposals will be considered by the EU<br />

parliament and the European Council. At present,<br />

the target date for the legislation to be adopted<br />

is 2014, with the new regulations being brought<br />

into effect on a staged basis of possibly up to<br />

five years.<br />

Michael Goldberg<br />

Solicitor<br />

London<br />

m.goldberg@kennedys-law.com<br />

8

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