HL7 delivers healthcare interoperability standards

COCIR-CEN-CENELEC Workshop on Medical Software

Regulating Medical Software Challenges at European and International Levels 

  • 12 October 2011 - 9:30-18:00 
  • CEN-CENELEC Management Center Avenue Marnix 17 - 1000 Brussels, Belgium

This is an opportunity to learn more about regulations applicable to software used in medical practice, with a focus on the pre-market aspects and support of European standards: what regulation is applicable to which software, and how compliance with that regulation can be achieved. The amendment to the medical devices directives by 2007/47/EC, in force since 21 March 2010, recognized that standalone software can be a medical device and thus regulated. Since that date, however, there is some uncertainty as to which software actually IS within the scope of the directive.

  • Latest updates on current medical software regulations & international comparison
  • International and EU standards supporting regulations
  • Complying with regulations: practical examples
  • Brief outlook into the future

Last modified 12/09/11