Medical Device Trials in the EU: A Guide to the New EU-MDR and Revised ISO 14155

If your device requires clinical trials under EU-MDR, there’s a lot to learn.

The world of clinical trials is changing rapidly, with the EU-MDR’s new and more complex rules and the forthcoming ISO/DIS 14155:2018 updates. With all the requirements found in different places, you could spin your wheels searching through article after article, jumping to annexes and back to more articles.

The Medical Device Trials in the EU: A Guide to the New EU-MDR and Revised ISO 14155 management report explain these requirements and concepts in a comprehensive, easy-to-understand approach:

• Understand the role of clinical trials in the EU-MDR
• Learn which device types require clinical trials
• Determine whether an exemption applies to your device
• Learn how to integrate the EU-MDR and ISO/DIS 14155:2018
• Understand the role of the Notified Body and Competent Authority
• Grasp the format and contents of the application, investigator’s brochure and clinical trials plan
• Determine informed consent requirements

Make sure you fully understand the EU-MDR’s and ISO/DIS 14155:2018’s clinical trials requirements — how they work together and how to make them work for you. Order your copy today.

Who Will Benefit

• Sponsor’s R&D staff
• Principal investigator
• Regulatory affairs staff
• Clinical affairs/operations managers