The European Commission has officially adopted a new Directive that is of critical importance to most medical device companies selling and/or conducting clinical trials in Europe. The new Directive 2007/47/EC amends parts of the Medical Devices Directive (93/42/EEC), the Active Implantable Medical Devices Directive (90/385/EEC) and the Biocidal Products Directive (98/8/EC).

The changes to the Medical Devices Directive are the first significant changes in 14 years. The existing Medical Device and Active Implantable Medical Devices Directives remain in force and are amended by this new Directive. All EU member states must transpose this Directive into their national law by December 21, 2008 and the new Directive will be mandatory as of MARCH 21, 2010. 

We will provide you with a more detailed assessment and overview of the changes and how these may affect you, but we did not want to delay informing you about the arrival of Directive 2007/47/EC. Some of the major changes will require your immediate attention and in order to be in compliance with those changes by March 2010, you should start planning and, in some cases, take action as soon possible.

As we have reported to you previously, the need for clinical data and clinical evaluation as part of your technical documentation (including low and medium risk devices) will require your close attention and action.  Also, Post Market Surveillance including vigilance is strongly emphasized in the new Directive and require immediate changes to your current procedures and processes in place. This immediate action is also triggered by the new European MEDDEV 2.12-1 Rev 5 guideline on vigilance. Even though the Guideline is not legally binding, some member states are adopting these guidelines into their national legislation which makes it mandatory to meet these requirements.

You can download a PDF copy of Directive 2007/47/EC by visiting the European Regulations section of our Learning Library or by clicking on this link:
http://www.emergogroup.com/documents/Learning_Library/EuropeDOCUMENTS/2007-47-EC.pdf

Next week we will provide an update on the specific changes made to the MDD as a result of the publication of this Directive.

Regards,

Evangeline Loh, PhD, RAC
Director of Regulatory Affairs
Emergo Group, Inc.

P.S. President Bush has signed into law a new bill that changes the user fees the US FDA will charge companies starting on 1 October 2007. Major changes have been made to the fees charged for PMA and 510(k) submissions. Most notably, the FDA will start imposing a new annual registration fee of US$1,706 to all companies registered with the FDA. We will email you more details next week along with the overview of the MDD changes mentioned above.