Wednesday, Oct. 30, 2019
2 p.m. Eastern time / 11 a.m. Pacific time
With the transition end date from the European Medical Device Directives (MDD 93/42/EC and MDD 90/385/EEC) to the new European Medical Device Regulations (E.U. MDR 2017/745) approaching on May 26, 2020, we are less than a year away from the most significant change in European medical device regulations since the 1990s.
The MDR brings several highly impactful changes, noteworthy whether you are a small or large medical device developer, manufacturer, supplier, contract research organization (CRO) or notified body. For example, the fact that the E.U. MDR is a regulation, not a directive, means it has binding legal force throughout all E.U. member states. Failure to meet compliance requirements could now have more costly legal repercussions.
E.U. MDR emphasizes patient safety, stipulating greater transparency, traceability and clinical evidence in support of product safety and efficacy claims. It focuses on the product life cycle, which is evident in the major categories of change, including the European Data Bank on Medical Devices (EUDAMED), supply chain, clinical evidence and investigations, post-market surveillance, and notified bodies responsibilities.
Join this free webinar to gain insights into requirement shifts surrounding clinical evaluations and data. Whether you’ve been long planning for E.U. MDR or taking the ‘wait and see’ approach, stay informed of the latest developments in interpretation, guidance and timelines. Get best practices on how to plan for E.U. MDR, and discover what options clinical research organizations have.
Attendees of this webinar will learn:
- Why and how the new E.U. MDR regulations came about
- How to take appropriate steps to ensure you’re prepared
- About E.U. MDR’s emphasis on clinical evaluations and investigations – and why this matters
- Why E.U. MDR necessitates eClinical platforms that boost efficiency, accuracy and compliance
Founder and Principal
Medical Design & Outsourcing