Sep 1, 2007
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.
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.
The EU has just released an important guidance document that should be read by every company selling medical devices in Europe.
The European Commission may extend its Transparency Directive covering pricing and reimbursement transparency of medicinal products to medical devices. EU regulators have launched a public consultation in conjunction with a process review of the Transparency Directive (89/105/EEC) intended to revise pharmaceutical pricing rules, which have not been updated since 1989.
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.