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Premarketing Regulation - Application Process
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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
Notified body TÜV PS calls for competent authority action in Europe
23 July 2010
Amanda Maxwell
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 ...
LATEST FEATURES
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 ...
In Vitro Diagnostics - Global Supply Chains, Global Regulatory Challenges
22 June 2010
Sharon Williams discusses the regulatory hurdles for IVDs. The in vitro diagnostics industry represents one of the most lucrative segments in the ...
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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
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