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.
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.
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
Who should attend?
Clinical and Regulatory Affairs Professionals, Medical Device R&D Engineers and Scientists.
Pre-requisites
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
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)
What's included?
On completion, you’ll be awarded an internationally recognized BSI Training Academy certificate.
