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Regulatory Region - Europe
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EXPERT VIEW
In praise of the CE marking, but medtech's worst fear is still alive
06 July 2010
Ashley Yeo
The European Medicines Agency review meeting in London on 30 June passed with scarcely a mention of devices and diagnostics. This was perhaps as expected, given that the meeting, held to examine the outcomes of the assessment of Ernst & Young's ...
INTERVIEW
EU must tackle clinical trials shortfalls as current lack of evidence is "appalling"
30 July 2010
Amanda Maxwell
With devices becoming increasingly complex, competent authorities in the European Union must ensure there are sufficiently well-trained experts at ...
LATEST FEATURES
EU must tackle clinical trials shortfalls as current lack of evidence is "appalling"
30 July 2010
With devices becoming increasingly complex, competent authorities in the European Union must ensure there are sufficiently well-trained experts at ...
Notified body TÜV PS calls for competent authority action in Europe
23 July 2010
TÜV Product Service , one the main notified bodies for medical devices in the European Union, is in no doubt that the basic EU medtech regulatory ...
GHTF from the EU Industry's Viewpoint
09 July 2010
Eucomed's John Brennan talks to Karen Finn about Global Harmonization Task Force efforts on UDI and nomenclature, and the impact the GHTF may have on ...
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LATEST COUNTRY PROFILES
Trademarks Briefing (Devices) - Luxembourg
08 October 2009
Please give details of the major acts and directives governing trademarks. Trademarks are governed in Luxembourg by the: Benelux Convention on ...
Regulation of Medical Devices Briefing - Spain
08 October 2009
1) Which authority is responsible for overseeing the regulation of medical devices and diagnostics in Spain? Agencia Española del Medicamento, the ...
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MULTIMEDIA
RAJ Devices News Roundup, July 2010
19 July 2010
PEOPLE
Getinge chief exec Lindoff is new Swedish Medtech chair
Swedish Medtech , the Stockholm-based national medical technology industry association, has appointed Joacim Lindoff as its chairman. Mr Lindoff, ...
UK knighthood for NICE chief executive Dillon
Andrew Dillon , chief executive of the UK's National Institute for Health and Clinical Excellence , has been awarded a knighthood for services to ...
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