LATEST NEWS

Regulatory Reform

Friday 3 July 2009

Australian reform proposals progress through parliamentLegislation aimed at improving and clarifying the regulation of therapeutic goods in Australia, including medical devices, is progressing through parliament.

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Postmarket Surveillance

Friday 3 July 2009
US FDA improves electronic device reporting system coding – update


European Commission updates its borderline products manualEuropean Commission updates its borderline products manual

Friday 3 July 2009
The European Commission has published an updated version of its manual on the classification of borderline products that contains opinions on new products.

Global medtech network to strengthen its voiceGlobal medtech network to strengthen its voice

Thursday 2 July 2009
An international network of medtech industry associations is working on formalising its procedures and activities in an effort to be recognised as a single voice, similar to that of the international pharmaceutical industry federation, the IFPMA.

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LATEST ANALYSIS

Don't Need a Clinical Trial for a CE Mark? Think Again.Don't Need a Clinical Trial for a CE Mark? Think Again.

Wednesday 24 June 2009
John O’Dwyer and Claire McKenna warn that medical device companies seeking to market their products in Europe will no longer be able to bank on avoiding a clinical trial.

How to Comply with the New AdvaMed Code of EthicsHow to Comply With the New AdvaMed Code of Ethics

Friday 22 May 2009
US medical technology industry association AdvaMed is poised to launch a much stricter version of its code of ethics to ensure that companies and healthcare professionals interact in such a way that removes any cloud of impropriety. Andrew Van Haute describes the new code and explains how companies can familiarise themselves with it.

Liability of Authorised Representatives and Importers under the EU MDD Liability of Authorised Representatives and Importers under the EU MDD

Friday 22 May 2009
Philipp Reusch discusses new liability issues that could arise when amending Directive 2007/47/EC comes into effect in March 2010.

The Role of the Manufacturer in a Multisite OrganisationThe Role of the Manufacturer in a Multisite Organisation

Friday 22 May 2009
Jan van der Kuil addresses the problems that arise from the requirements for monitoring and control of quality systems within multisite organisations.

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Freetrial

COMMENTS

Regulatory Focus

Friday 13 March 2009
The European Commission insists that no formal decision has been taken to postpone the proposed recast of the Medical Devices Directive. At the same time, however, as we report in this issue, industry commissioner Günter Verheugen has told the German medtech industry association BVMed that no formal proposals were likely to be issued in 2009.

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REFERENCE

Download the latest recently updated and newly issued regulatory guidelines and legislation here for free.

May/June 2009 guidelines


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PEOPLE

New health secretary, ministers appointed at English DoH

Wednesday 1 July 2009
Andy Burnham is the new Secretary of State for Health for England, replacing Alan Johnson.

Helliwell appointed NICE vice chair

Wednesday 1 July 2009
Margaret Helliwell has been appointed vice chair of the UK National Institute for Health and Clinical Excellence.

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