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Event info
Date:07 Dec
Time:14:30 - 18:30
Venue:Medicon Valley Alliance HUB2, Copenhagen


Contact person
Katrine Brems Olsen

Katrine Brems Olsen

Network & Event Manager

+45 2337 0040

MDR and IVDR in the EU: documentation and clinical evidence – the struggle is real (and the way forward)

The introduction of IVDR and MDR, in European Union, brought considerably increased regulatory expectations especially in the area of clinical evidence for the industry. Those changes found the industry intrinsically unprepared and lagging the initiative driven approach needed to close the regulatory gaps generated.

The state of Clinical Evaluation, PMCF activities and ultimately clinical evidence is now in the center of all compliance efforts. An important consideration for al manufacturers how can all those activities become sustainable long term. Hence, the meeting will focus not only on current successful practices on EU/MDR clinical activities, but also on strategies for continuous collection of data that can create a sustainable data creation process for a device entire life-cycle.

At the meeting we will also hear the industry vision on the future regulatory framework for medical device and explore MedTech Europe’s initiative, co-signed by the Danish and Swedish MedTech industry associations, as they advocate for a comprehensive reform of IVDR and MDR in their letter to the European Commission.

The aim of the meeting is to provide the basis for knowledge sharing and a fruitful dialogue around core issues of clinical evidence and sustainability of clinical evidence collection.

Date: Thursday 7th December, 2023
Time: 14.30 – 18.30
Venue: Medicon Valley Alliance, Arne Jacobsens Allé 15, 2300 Copenhagen S, Denmark – Meeting room: Auditorium



14:30 Registration and networking
15:00 Welcome and introduction
Anette Steenberg, CEO, Medicon Valley Alliance
15:10 Sustainability and Clinical Evidence Creation under EU-MDR – a lifecycle management approach
Dr. Efstathios Vassiliadis, CEO, Evnia 
15:30 If it isn’t documented it doesn’t exist! – A presentation about the challenges with the technical documentation for a medical device
Micael Johansson, Senior Regulatory Affairs and Quality assurance consultant, Prevas AB 
15:50 Impact of the amended EU regulation to MDR for Business Area Acute Care Therapies within Getinge Group
Mikael K. Johansson, Senior Director, Getinge Group
16:05 Networking and cake
16:35 Industry vision on the future regulatory framework for medical devices
Lene Laursen, COO, Medicoindustrien
16:55 Panel discussion and Q&A
Moderated by Dr. Gitte Juel Holst, Clinical Study Manager, Evnia
17:30 Should your Medtech invention be part of the new Unified Patent Court (UPC)?
Peter Borg Gaarde, Partner, European Patent Attorney & UPC representative, Høiberg
17:40 Networking and snacks
18:30 End of Network Meeting


Deadline for registration is 4th December, 2023.


Dr. Efstathios Vassiliadisis the founder and CEO of Evnia, a leading-edge regulatory and clinical affairs organisation specialised in Medical Devices and In Vitro Diagnostics. Dr. Vassiliadis has 22 years of experience in the medical device/IVD field, combining knowledge from academic, commercial, clinical, regulatory and production. Evnia’s is supporting medical device manufacturers globally in their quest to bring their devices and innovation in the European Union, USA and regulatory adjacent markets.
Micael Johansson has been working with quality, regulatory and product development all his life and more than 20 years with medical devices. He has a background at Intertek SEMKO (Teamleader), Getinge (Regulatory affirs Manager) and various consultant roles since 2011. He work with all from startup-to international companies. Micael participates in three standard committee’s and holds the Chairman position for Medical Device section at Apotekarsociteten.
  Mikael K Johansson carries a Master of Science in Industrial Engineering & Management from Linköping University and has worked 28 years in the global med tech industry whereof the past 21 years for Getinge Group. He has held executive positions within Getinge since 2006 including heading the product segments Advanced Monitoring and Cardiopulmonary located in Germany. Mikael is since five years leading the EU MDR implementation program for Business Area Acute Care Therapies ranging over 69 product groups in various product segments that are developed and manufactured by in total 10 sites located in Germany, Sweden, France and the U.S.
Lene Laursen holds a Master of Law and has been working for the Danish medical device industry organization Medtech Denmark more than 20 years. Medtech Denmark has app. 230 member companies within the Medtech sphere, covering both big, small- & medium-sized and start-up medtech companies.
Dr. Gitte Juel Holst is Clinical Study Manager of Evnia. She has an educational and scientific background in public health with over 10 years of experience in research, scientific communication, teaching, supervision, and contribution to successful national and international interdisciplinary collaborations. As Clinical Study Manager she is specialised in Post-Market-Clinical-Follow-Up registry studies with responsibility for planning, coordinating, and monitoring clinical registries which aim to document and evaluate the safety and performance of medical devices used by healthcare professionals in clinical practice to the benefit of patients.


Medicon Valley Alliance Medtech Network gathers the region’s medtech industry to create new partnerships and business opportunities. Joining the network is free of charge for Medicon Valley Alliance members interested in gaining new insights, sharing experiences and networking with like-minded organisations. Non-member organisations and companies are welcome to attend one network event to evaluate membership.


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