2012 medical device eUpdates

December 2011

Dr. Gert Bos, BSI reports on the productive meeting held today in Europe’s centre of Brussels, the European Medical Device Expert Group (MDEG) ratified seven new and revised guidance documents.

MEDDEV 2.12-1 rev.7
The guidelines on a Medical Device Vigilance system (MEDDEV 2.12-1 rev.7 ) have been reviewed and updated to include the new Manufacturers  Incident Report Form and the FSCA Form (listed as Annex 3 & 4) on the basis of experience.
In addition, templates for Manufacturers Trend Reporting and Manufacturers Periodic Summary Reporting (Annex 7 & 8) are being introduced, moving from reaction to prevention where possible. The reporting forms are based on GHTF templates. They will be made available in XML format, including instructions for use, in anticipation of the European database (EUDAMED) being ready for electronic input.
Details on reporting to Turkey have been added, and clarification has been provided for cases where a device does not directly come in contact with patients, such as in IVF/ART (In Vitro Fertilization). In addition a number of additional scenarios in reportable events have been added. Clarification on IVD reporting may be clarified in the next revision, scheduled for Spring 2012.
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