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Vigilance is Not Enough

London, August 4, 2005 -- Design for patient safety is a central issue for the current UK health Presidency of the EU. The Journal of Medical Device Regulation (JMDR) has published an article written by Dr David Jefferys entitled Beyond Medical Device Vigilance which addresses some of the most crucial issues of current medical device vigilance systems.

Vigilance alone is not sufficient to ensure patient safety

According to Dr Jefferys, the post-marketing surveillance of medical devices has reached an interesting stage. "The vigilance system remains the bedrock of the system but it has to be supplemented by other approaches", concludes Jefferys. "This may become increasingly important especially as the nature of the medical device product changes".

FDA's Office of Combination Products ISO 14698 Human and animal tissue regulation AG MPG

In further focus articles in the August issue of the JMDR, experts from the medical device community discuss topical issues concerning combination products, microbiology and advanced therapy products. The JMDR is published primarily in the English language but includes summaries of all articles and news in German, French and Spanish. The article on the German Industry Association Task Force on the Medical Device Act (AG MPG) by Rainer Hill from BVMed, Germany is written in the German language, with abstracts in English, French and Spanish.


The Journal of Medical Device Regulation is intended to educate, provide professional guidance, develop core competence of regulatory professionals, and promote debate on fundamental and topical matters within the medical device industry. In addition to publishing review and discussion articles by opinion leaders from the device community, the Journal summarises the news headlines from around the world and provides useful reference information in the form of charts and briefing documents. The Journal is a quarterly, subscription-only publication which is currently only available in electronic format. The full articles are only accessible to subscribers of the JMDR.

For further information

For more information on the Journal of Medical Device Regulation please contact Victoria Clark at Global Regulatory Press, phone number +44 (0)1305 770836 or visit the Global Regulatory Press website at

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