Course description

The course is designed to provide you with an understanding of the clinical evaluation process including details on the regulatory requirements, the principles of clinical evaluation, how they are performed and documented. 

Practical activities throughout the day provide the opportunity to apply your skills in order to perform a clinical evaluation within your organization upon completion of the course.  

Course aim

This one-day intensive course enables you to gain a detailed understanding of the clinical evaluation process for medical devices against the requirements of the Medical Device Regulation (MDR - EU 2017/745), MEDDEV 2.7/1 Revision 4 and relevant MDCG guidance documents.

How will I benefit?

This course will help you to:

• Identify the requirements of clinical evaluation against the Medical Device Regulation (MDR - EU 2017/745), MEDDEV 2.7/1 Revision 4 and relevant MDCG guidance documents
• Determine when clinical evaluation is undertaken and the frequency of updates
• Interpret and communicate the key requirements and expectations of medical device clinical evaluation to your organization

Apply the clinical evaluation process for medical devices within your organization

What will I learn?

Upon completion of this training, you will be able to:

• Identify the key requirements for clinical evaluation according to the MDR, MEDDEV 2.7/1 Revision 4 and relevant MDCG guidance documents
• Explain the principles of clinical evaluation
• Outline the stages of the clinical evaluation process and documentation requirements
• Define how clinical evaluation is performed, including details on clinical evaluation plans (CEP), demonstration of equivalence, identification and appraisal of data and analysis of clinical data
• Determine when a clinical investigation is needed for your device
• Explain the post-market clinical follow-up (PMCF) requirements
• Define the requirements of a clinical evaluation report (CER)

Who should attend?

Clinical and Regulatory Affairs Professionals, Medical Device R&D Engineers and Scientists.

Duration

1 days

How will I learn?

Our unique accelerated approach fast-tracks learning, improves knowledge retention and ensures you acquire the skills to apply your knowledge straight away. This course involves practical activities, group discussions and classroom learning to help you develop a deeper understanding of the material and have a greater impact on job performance.

What will I gain?

On completion, you’ll be awarded an internationally recognized BSI Training Academy certificate.

Prerequisites

Familiarity with your own device, clinical safety and performance issues.

Awareness of:

• General Safety and Performance Requirements (Annex I), Clinical Evaluation and investigations (Annex XIV and XV) of the MDR - EU 2017/745

MEDDEV 2.7.1 Revision 4 and relevant MDCG guidance documents

Further information

Detailed course notes and lunch will be provided.

Related training

Requirements of the Medical Device Regulation (MDR) Training Course, Implementation of the Medical Device Regulation (MDR) for CE Marking Training Course and Medical Device Directive (MDD) to Medical Device Regulation (MDR) Transition Training Course.