Medical Devices and legal issues at the interface of regulation, protection and Innovation”

Activity: Participating in an event - typesParticipation in workshop, seminar, course

Timo Minssen - Organizer

On 16 January 2023, CeBIL Director Timo Minssen organized and moderated the Seminar on “Medical Devices and legal issues at the interface of regulation, protection and Innovation” in collaboration with colleagues from the Danish Association for the Protection of Industrial Property Rights (FIR). On 25 May 2017, two major regulatory changes entered simultaneously into force, which are highly relevant for medical device manufacturers: EU Regulation 2017/745 on medical devices (MDR) and EU Regulation 2017/746 on in vitro diagnostic medical devices (IVDR). [1] In reaction to the COVID-19 pandemic's impact on medical device stakeholders, the application date for the MDR had been postponed from May 2020 to May 2021. While this gave stakeholders more time to prepare for the new regulatory framework, it is evident that many uncertainties and challenge remain to be addressed in light of new technical developments. This also concerns the broader legislative framework within which the European medicine agencies and the so-called notified bodies will have to operate. In addition to product specific regulations, various stakeholders will have to consider a great number of recent laws, guidances, policy papers and strategy announcements dealing with topics ranging from health data protection, social justice and cybersecurity to liability, competition law and intellectual property rights. This hybrid seminar featured a group of highly respected practitioners and young scholars who discussed these developments and the associated opportunities, challenges and risks from a practical law & tech perspective.
16 Jan 2023

Seminar

SeminarMedical Devices and legal issues at the interface of regulation, protection and Innovation”
Period16/01/2023 → …

ID: 378389373