Author: Criterion Edge Writers
Concerns and frustration surrounding the implementation of Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) were voiced in early May at MedTech Europe’s 2022 Forum in Barcelona. Two notable sessions that discussed MDR and IVDR implementation were reportedly lively and filled to capacity. The chairs of these sessions, Marc Pierre Möll, CEO of BVMed, and Oliver Bisazza, MedTech Europe’s Director General of Industrial Policies and External Affairs, shared their reflections on these discussions in Barcelona and the current impacts of MDR in an interview with MedTech Insight.
How much do we know about what is happening in relation to unconfirmed reports that some European notified bodies have over-stretched themselves and are failing to deliver adequate services to their medtech clients?
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In this discussion, we provide an overview of how to plan and coordinate change within an organization to meet upcoming EU IVDR regulatory requirements. We will be highlighting key steps involved in helping medical affairs transition to a more rigorous regulatory environments, and how to evaluate talent gaps, team leadership composition, and process challenges of your product portfolio.
In this discussion, our panel of proven leaders discuss the key elements that support and propel the innovation process in the medical device, pharmaceutical, and IVD industries. We will be highlighting key areas of the process, important players in the pathway to the market, and how successful innovations spawn new innovations in new markets such as the digital health space, and more.
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