News and Views April 2012
2. Revision of the Medical Devices Directive (state of play)
The Commission conducted at the beginning of the year two meetings to present initial proposals for discussion. The first meeting was allocated for the MDD and AIMDD and at the second meeting the IVD update was presented. It now is almost sure that the MDD and AIMDD will be combined in one regulation and the IVD will stay as a separate directive. As you know the directive is directed to the member states and the legal term Regulation in Europe refers to a law, which is directly applicable without any national transposition. Directly applicable does not imply that the regulation is to be applied immediately. A regulation may as well stipulate a transition period when it is supposed to be mandated.
Currently the new version has not been published on the EU website. It was distributed to the various stakeholders only. Significant comments were given which means that a number of changes will be implemented. It is also evident that new concepts developed with the guideline will now be part of the regulation. This is good in terms of the clarity of certain requirements but it also limits the freedom of the manufacturer to develop alternative solutions.
A new version may be given to the stakeholder in June for the
next MDEG meeting but the new regulation is not expected to be released
any time soon. The whole project will take some time and under certain
circumstances (no agreement among member states) it may take still
several years. In any case we recommend to closely monitor the overall
recast in order not to miss any opportunity to react on any aspects
related to your products.
A good starting point would be here: http://ec.europa.eu/health/medical-devices/documents/revision/index_en.htm
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