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The new Medical Device Regulation (MDR) - how does it affect healthtech companies?

Friday, 23 October, 2020 - 09:00 to 10:00

What does the new regulatory map look like based on new rules for software classification in MDR compared to MDD? How do I best set up the plan for a reclassification - from class I to class IIa or higher? What does my company need to do right now? Join our webinar about the new Medical Device Regulation (MDR) and how it will affect healthtech companies. 

Within the EU, the new regulation for medical devices, the Medical Device Regulation (MDR), has replaced the Medical Device Directive (MDD) and Active Implantable Medical Devices (AIMD). From May 2021, the new regulations (MDR) must be applied to CE marking. This has a major impact on everyone who manufactures and develops medical devices and perhaps especially on you who work with software where more products now end up in a higher risk class than before. Welcome to a webinar where you get an overview of what applies to you who develop and manufacture products in digital health, e-health and healthtech.

Speakers:

  • Johanna Fugelstad, Senior Consultant Clinical Evaluations, Key2Compliance
  • David Hedfors, Quality and Regulatory Affairs Director, RaySearch 

More information about the webinar >>

Please note that this webinar will be held in Swedish.

The registration is now closed, please contact anna.frejd@ssci.se if you would like to participate!