Medical Device Regulation (MDR) 

How are the future perspectives of medical devices? 

New requirements are placed on the development and documentation of medical devices, due to the new MDR regulation.

This track gives you insight into the different elements of MDR and brings the region’s usage of Article 5.5 (in-house) into play. It touches on the usage of artificial intelligence followed by debate.

We pay attention to the elements of the new MDR regulation, including technical documentation, quality management system and clinical documentation.

We give you an insight into the regions’ use of Article 5.5 (in-house), which gives the regions the opportunity to develop and use medical devices themselves.

Finally, we touch on artificial intelligence, which is included in a debate.

This event is in Danish.


13.30-13.35 Welcome and introduction
Marlene Højstrup Jensen, Danish Life Science Cluster  

13.35-14.05 MDR: Technical documentation, Quality Management System and Clinical Documentation – Medical Device Regulation  
by Niels Peter Lindholt, CE Toolbox

14.05-14.35 Article 5.5 (in-house):  The Regions perspective and usage of article 5.5 (in-house)
by Kirstine Louise jensen, Region Syd, MDR-specialist, & Jeanette Bak Christensen, Region Midt, Special Consultant, MDR-Management Secretariat

14.35-14.55 Break and networking 

14.55-15.15 The usage of AI in medical devices 
by Claus Lindholt, CE Toolbox

15.15-15.55 Debate: Future perspectives of MDR and the usage of Artificial Intelligence
Moderator: Niels Ole Andersen, NoaQA, Regulatory Expert, Medical Devices

15.55-16.00 Summary and rounding  


Time & place

Thursday 9. November
Healthcare Denmark

Arranged by

Danish Life Science Cluster & CE Toolbox


Marlene Højstrup Jensen
Community Manager
Danish Life Science Cluster
T: +45 2856 0103
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