Aug 26, 2008
Another version (1.1, May 2008) of the Manual on Borderline and Classification in the EU Community has been published.
Version 1.1 adds approximately ten new examples. While this is guidance and many of the products may not be relevant, they do provide examples and capture the opinions of various regulatory officials.
One example of note is the classification of different types of Picture Archiving and Communication Systems (PACS).
Other examples:
The European Commission has issued a revised version of MEDDEV 2.12-1 which provides guidance to industry and Competent Authorities on how to meet the medical devices vigilance system requirements.
The Neurological Devices Panel of the US Food and Drug Administration’s Medical Devices Advisory Committee will hold a public meeting on February 10, 2012 to consider
On 7 July 2010, the newly issued list of standards (considered European norm harmonized to the directives) was published in the Official Journal of European Communities (OJEC). To this end, each directive has a corresponding list of applicable standards. The list appropriate to the directive can be referenced here: MDD, IVDD, and AIMDD.