And Now for Something Completely Different: Why Europe’s Regulatory System for Medical Devices Works

As noted in the Daily Buzz yesterday on emdt.co.uk, there has been something of a feeding frenzy among the media questioning the efficacy and safety of Europe’s regulatory system for medical devices. One of the more colourful comments is attributed to Nick Freemantle, Professor of clinical epidemiology and biostatistics, writing in the British Medical Journal. “The current European regulatory framework … might provide sufficient safeguards for electric toasters and kettles,” he notes, “but it is not adequate for treatments that can affect symptoms, health-related quality of life, serious morbidity and mortality.”

This might be a good time to step back from the overheated rhetoric and gain a more nuanced perspective on the “new approach” directives and the regulatory system they underpin. My recommendation is to read a column authored by Dr. Maria E. Donawa, President of Donawa Lifescience Consulting, titled “European Device Regulatory Revolution: A Personal View.” Donawa acknowledges the system’s shortcomings, but, compared with the alternatives, it has a lot going for it. “I have always believed that the European regulatory framework for medical devices is, in many ways, an elegant approach to regulating an exceedingly complex array of products.”

That may not make the headlines, but it needs to be said.

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Tags: Donaway, Europe's regulatory system for medical devices, medical device directives, New approach directives, Regulatory framework