Regulatory framework for active implantable medical devices is required to be transposed into national law 15 months after its date of publication which is 21 December 2008

Transpositions of medical device directives

TRANSPOSITION OF THE MEDICAL DEVICE DIRECTIVES

Pilot program concerning the transposition into national law of Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market.

The pilot program in the implementation of Directive 2007/47/EC is basically a "pre-adoption screening procedure". This procedure will allow the Commission, Member States, industry and individuals to participate in the implementation process.

This tool of better regulation allows the different competent authorities, both at Community and national levels, to prevent problems ex ante thus avoiding costly and controversial infringement proceedings which can only be launched ex post. The exchange and gathering of information is also an effective way of ensuring that national best practices become known and are used as a model for other regulatory initiatives.

The recently adopted revised regulatory framework for medical devices is required to be transposed into national law 15 months after its date of publication which is 21 December 2008.

Those Member States which have confirmed their participation for the pilot program have been asked to submit their draft national legislative text (transposing Directive 2007/47/EC) to the Commission services.
The draft national legislative texts which have been communicated and on which you may send comments can be found here.

You may send comments on these draft national measure of transposition until the date which is indicated on these measures to email address ENTR-MD-2007-47@ec.europa.euWhere you wish that your identity will not be made available to the national authorities, you will need request this when submitting your comments. The Commission services shall assemble all comments made and send their conclusions to the Member State in question, within three months following the publication of the draft on the website.It should be noted that the application of this procedure does not prejudice the application of Directive 98/34/EC, in case, for example, where the national text incorporates provisions not related to the transposition of Directive 2007/47/EC.Directive 2007/47/EC available as pdf in various languages

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