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News and Views March 2017

New Medical Device Regulation (MDR) in Europe
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Manual on borderline and classification

in the community regulatory framework for medical devices (06-2013)

The European Commission has published a new version (1.15) of the Manual on borderline and classification for medical devices in June this year. The English text can be found here:

http://ec.europa.eu/health/medical-devices/files/wg_minutes_member_lists/borderline_manual_ol_en.pdf