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Revision 0, 07 April 2008
Client information note –
MDD - Revision to the Medical Devices Directive
This Client Information Note introduces the revisions to the Medical Devices Directive 93/42/EEC
published as Directive 2007/47/EC.
Discussions between notified bodies, the industry and competent authorities have already identified
areas of the new regulations that will require further guidance.
The Medical Devices Directive (MDD) was subject to a commission review on its functioning. In
summary, the conclusions were that the existing legal framework is appropriate, but that its
implementation could be improved, including further regulatory clarification.
Therefore, the Directive has not been rewritten but has been amended by the publication of Directive
Some of the changes affect the implementation of the regulations at Community level and take on
board general principles of the ‘new approach’.
This note focuses on some of the changes that will, or may, affect manufacturers.
the amending regulations were published in the Official Journal of the European Union on
21 September 2007as Directive 2007/47/EC
the new directive amends not only the MDD but also the Active Implantable Medical Devices
in line with the findings of the Commission review, the directive amends the existing MDD. It
is not a new stand-alone MDD. The Directive therefore only provides text relating to the
you can download the new directive in various European languages from the following link:
although not a ‘legal’ document within the framework of the regulations, the Commission has
also released a consolidated version of the regulations which you may find easier to work with.
You can download this from the following link: