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Postmarketing Regulation - vigilance
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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 ...
LATEST FEATURES
UK regulator highlights EU post-market surveillance failings
19 May 2010
It is “staggering” how many manufacturers fail to fully fulfil their legal responsibility to collect product data in the post-production phase, ...
Meeting New PMS and Vigilance Requirements in the EU
17 May 2010
Alex Denoon and Erik Vollebregt analyse the post-marketing surveillance obligations introduced in March. Post-marketing surveillance (PMS) ...
Advanced Therapy Medicinal Products in the EU: Navigating the Regulatory Maze
10 March 2010
Ralf D Hess explains the complex regulatory framework that manufacturers need to consider when seeking marketing authorisation of ATMPs in Europe. ...
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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 ...
>> More Latest Country Profiles...
MULTIMEDIA
RAJ Devices News Roundup, July 2010
19 July 2010
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