Changes on the way for Medical Device conformity
18th April 2008 by Simon Emeny
The Medical Devices Directive (MDD) 93/42/EEC is well established. As is common with the EU, they decided that it couldn’t be left alone and instituted a 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.
The Directive has not been rewritten but has been amended by the publication of a new document, Directive 2007/47/EC.
Some of the changes affect the implementation of the regulations at Community level and take on board general principles of the ‘new approach’.
Main points
• 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 Directive (90/385/EEC)
• 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 amendments
• you can download the new directive in various European languages from here
• 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. Follow this link
• The EU member states have 15 months (until 21 December 2008) to implement the Directive into national laws.
• The Directive becomes mandatory in a further 15 months (21 March 2010).
• Some of the revisions affecting manufacturers are actual changes to the existing regulations, others are considered to be clarifications which might require manufacturers to reconsider their current status of conformity and / or procedures.
Simon manages Product Conformity for both the