May 22, 2024

Decoding 'Sufficient Clinical Evidence' under EU MDR for Medical Devices

One of the most confusing parts of the clinical evaluation process is around clinical evidence sufficiency.

The MDR requires that the level of clinical evidence is justified and specified by the manufacturer during the clinical evaluation process. This must also be appropriate to demonstrate conformity with the relevant GSPR.

MDR defines this level of evidence as ‘sufficient clinical evidence’ but does not define what is considered sufficient.

It is incumbent on you as the manufacturer to determine what sufficient clinical evidence means for your device, based on its stated indication for use.

Join this live webinar where Kara Budor, Director of International Regulatory Affairs at MCRA, will discuss the background, definitions, guidance and practical application of the determination of clinical sufficiency to enable manufacturers to understand this critical and complex requirement.

Watch for free

Decoding Sufficient Clinical Evidence under EU MDR for Medical Devices
Specifically, this webinar will cover:
  • MDR requirements and definitions of clinical sufficiency & related MDCG guidance
  • Overview of clinical evidence generation options where sufficiency cannot be demonstrated
  • Feedback on common issues identified in Notified Body and MDCG Expert Panel clinical evaluation reviews
Who should attend?
  • Clinical Affairs Professionals and Management
  • Clinical Operations Professionals and Management
  • Regulatory Professionals and Management
  • Medical Device Executives
Register Now  

Hosted by

Kara B

Director, International Regulatory Affairs,

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Solutions Engineer,
Greenlight Guru

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About Greenlight Guru

Greenlight Guru is the leading connected, cloud-based platform purpose-built for MedTech companies. The end-to-end solution streamlines product development, quality management, and clinical data management by integrating cross-functional teams, processes, and data throughout the entire product lifecycle.

Greenlight Guru’s platform is used by organizations across the globe that are replacing their disjointed, legacy tools and solutions to bring life-changing products to people faster and with less risk.

Visit our homepage to learn more.

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About MCRA

We believe that MCRA's heritage of combining its integrated services in clinical trials has created a unique system including clinical research, regulatory, reimbursement, compliance and specialized therapy expertise.

Our global medical device CRO enables companies of all sizes to successfully execute clinical studies by streamlining the clinical trial process through an integrated approach that guides clients through the medical device lifecycle: from pre-clinical testing, to regulatory submission, market approval, and post commercialization.

MCRA's CRO executes medical device and medical device combination studies including pre-market & post-market (registries, post-approval, & retrospective). 

Visit their website to learn more.

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