Join our FREE Breakfastclub Webinar!
It’s time for another one of our FREE Breakfast Club Webinars!
Get your coffee ready on December 8th, 9.00 – 9.30 and take part in this knowledge sharing webinar!
Software classification and MDR – why are most MDSW not class I anymore and what does it imply?
During the MDD era, many Medical Device Software (MDSW) companies have been able to do their Software CE-marking themselves without involvement of any notified body. This is because of MDD annex IX classification rule 12 that puts most active devises in class I. Since the introduction of MDR however, the classification rules have changed, meaning that most (almost all) MDSW are class IIa or higher.
What does this mean for you as a manufacturer? What challenges do you see? Do you have a strategy to address the new challenges?
Welcome to join our experts Stina Gustafsson and Susanne Grimsby in the discussions about the MDR software classification and what it means for you as MDSW manufacturer!