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The Ambitious Work Programme of the European Commission

This article was originally published in SRA

Executive Summary

Someone has at last come out and said it - the revision of the European Union's (EU) Medical Devices Directive (MDD; Directive 93/42/EEC) that is underway has been far from the simple process it was meant to be. Speaking at a recent industry conference, Mike Kreuzer of the UK Association of British Healthcare Industries (ABHI) said: “All the way along the line people have said [it] was routine and straightforward. It has in fact been extremely complicated, it remains complicated and it remains in fact potentially quite dangerous for this industry.”

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