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