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
Program
| 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.
SPEAKERS
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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. |
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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. |
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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. |
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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. |
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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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