2017/745 Medical Device Regulation VI. The MDR Clinical Evaluation, referred to in the MDR section, sets out the requirements for clinical evaluation of the medical device and, where appropriate, for clinical investigation.

The Clinical Evaluation Training for Medical Devices provides an overview of the clinical evaluation process of medical devices according to the medical device regulation (MDR - EU 2017/745), MEDDEV 2.7/1 Rev 04 and related MDCG guidance documents.

Designed for personnel with a basic knowledge of general safety and performance requirements, this training aims to teach you how to explain the basic principles of clinical evaluation.

Exhibitor Profile

Medical device design, development and production etc. It includes the personnel in the management and management staff in the Quality Assurance / Engineering / Production units related to the life cycle and the Clinical Field Staff.

Prerequisites

• Awareness of clinical safety and performance issues within the medical device industry,
• Basic knowledge of 2017/745 MDR General Safety and Performance Requirements (Annex I), Clinical Evaluation and investigations (Annexes XIV and XV)
• About MEDDEV 2.7.1 Revision 4 and related MDCG guidelines

We strongly recommend that you have a basic knowledge for the success of the education.

What will I learn?

After completing this training you will be able to:

• Basic requirements for clinical evaluation according to MDR, MEDDEV 2.7/1 Revision 4 and related MDCG guidelines
• Clinical evaluation principles
• Stages of the clinical evaluation process and documentation requirements
• clinical evaluation plan (CEP),
• Demonstrating equivalence
• Identification and evaluation of data
• When a clinical trial is required for your device
• Post-market clinical follow-up (PMCF) requirements
• Requirements of the clinical evaluation report (CER), including details on the analysis of clinical data