Ep 16: Clinical evaluation is now more important than ever under EU-MDR

There is a new scrutiny on clinical evaluations in the European Union.At the same time, medical device manufacturers are challenged to satisfy the new regulatory requirements under EU-MDR because they are no longer able to claim “equivalence” to an existing device under revised criteria. In this episode, Florian Tolkmitt emphasizes the need to consider clinical evaluation as an important process, not simply a document for compliance. The key point here is that we have to start focusing on planning and project management in addition to having a solid understanding of regulatory requirements. There should be connectivity in operations of different departments so everyone is following the same benchmarks and acceptance criteria.About Florian TolkmittFlorian Tolkmitt is the founder and owner of PRO-LIANCE GLOBAL SOLUTIONS GmbH providing consulting services in all aspects of clinical evaluation, regulatory affairs, risk and quality management. He is an expert in clinical evaluation, post-market clinical follow up and post-market reporting compliance. As a co-founder and board member of RAPS Deutshcland e.V., he is very active in the regulatory community sharing his expertise and mentoring industry colleagues.About Let’s Talk Risk! with Dr. Naveen AgarwalLet’s Talk Risk! with Dr. Naveen Agarwal is a weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn.DisclaimerInformation and insights presented in this podcast are for educational purposes only. Views expressed by all speakers are their own and do not reflect those of their respective organizations.If you enjoyed this episode, consider becoming a free or paid subscriber. This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe