Understanding Electronic Labeling Requirements for EU Medical Devices Webinar
26 Feb 2014 - 26 Feb 2014 - WEBINAR
Wednesday February 26, 2014 - 10:00 AM EST to 11:30 AM EST
The recently issued EU Commission Regulation 207/2012 on electronic Instructions for Use (IFU) in medical devices, effective March 1, 2013, is applicable to devices covered by the AIMD (90/385/EC) and the MDD (42/93/EC). The regulation is heavily geared towards manufacturers performing and documenting additional risk assessments which take into account the volatility of technology. In today’s stringent regulatory environment where medical device manufacturers are often required to demonstrate traceability throughout the product lifecycle, accurate labeling is critical.