EU 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.
TORONTO (PRWEB) October 21, 2019
The European Medical Device Regulations (EU 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.
EU 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 EU MDR is a regulation, not a directive, means it has binding legal force throughout all EU member states. Failure to meet compliance requirements could now have more costly legal repercussions.
With this in mind, device manufacturers need to ensure they’re prepared for what’s to come. Join Verna Manty Rodriguez, Founder and Principal of Manty Medtech and Adjunct Lecturer of the Bioengineering Department at Santa Clara University in a live webinar on Thursday, October 31, 2019 at 10am EDT (2pm GMT/UK) where she will cover:
- Why and how the new EU MDR regulations came about
- How to take appropriate steps to ensure you’re prepared
- About EU MDR’s emphasis on clinical evaluations and investigations – and why this matters
- Why EU MDR necessitates eClinical platforms that boost efficiency, accuracy and compliance
For more information or to register for this event, visit The New EU MDR and What It Means for Medical Devices.
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