Recast of Device Directives: The Dialogue Continues, Sort of

Monday, September 15th, 2008

On 8 May, the European Commission (EC) launched a public consultation on the need to develop a new framework for the regulation of medical devices. It cited a number of reasons for engaging this dialogue, notably inconsistent safeguards for public health among member states, new technologies that the present directives ...

MHRA Publishes Guidance on UK Clinical Investigations

Sunday, July 27th, 2008

The Medicines and Healthcare products Regulatory Agency, the UK competent authority, has published an updated version of guidance relating to clinical investigations. The document applies to manufacturers that intend to carry out clinical investigations in the United Kingdom. The document covers all aspects of performing and reporting clinical investigations in the United ...