Jun 11, 2009
The EU has just released an important guidance document that should be read by every company selling medical devices in Europe. It provides guidance on an amendment to the original Medical Devices and Active Implantable Medical Devices Directives. Probably the most important part of the 2007/47/EC guidance for medical device companies is that the amended directive goes into effect on 21 March 2010 and there will be no transitional period. This means that companies must comply by March 21. There are other points you should read about as well. You can download the entire read our analysis of the changes made by 2007/47/EC to 93/42/EEC on our website.
The European Commission has issued an interpretative document (dated 5 June 2009) of Directive 2007/47/EC (which amends the Medical Devices Directive MDD 93/42/EEC and the Active Implantable Medical Devices Directive AIMDD 90/385/EEC).
In addition to recent draft regulations concerning medical devices and in vitro diagnostics, the European Commission has drafted additional reforms (“PIP Action Plan”) aimed specifically at greater control of Notified Bodies. The draft Regulation on Designation and Supervision of Notified Bodies and Recommendations for Audits and Assessments have been drawn-up by means of the Standing Committee-mechanism described in Article 7 of the MDD 93/42/EEC (and Article 6 of the AIMDD 90/385/EEC). Therefore, these changes are expected much sooner than the impending legislative revisions. The Commission documents are expected to be released before the end of 2012 and the changes will likely be implemented as soon as 2013.