This one-day course offers a robust overview of the clinical evaluation process for medical devices against the medical device regulation (MDR - EU 2017/745), MEDDEV 2.7/1 revision 4 and relevant MDCG guidance documents.
Designed for clinical professionals with a base understanding of general safety and performance requirements, this training teaches you how to explain the key principles of clinical evaluation. During this stage of your learning journey, you will gain skills to determine when your device requires clinical investigation and you will leave with a full grasp of the clinical evaluation process.
How will I benefit?
- Fully grasp clinical evaluation requirements in line with the Medical Device Regulation (MDR - EU 2017/745), MEDDEV 2.7/1 revision 4 and relevant MDCG guidance documents
- Able to explain 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?
- Medical Device R&D Engineers and Scientists
- Clinical and Regulatory Affairs Professionals
What will I learn?
- Determine whether or not a clinical investigation is required for their device
- Prepare a clinical evaluation in accordance with MED DEV 2.7.1 and GHTF Guidance Documents
- Implement risk evaluation pre/post review
- Establish design and intended use equivalence with competitor and pre existing designs
- Identify data available from the clinical literature
- Supply and prepare documentation relating to clinical investigations that meets Notified Body requirements (if clinical investigation was deemed necessary and completed)
- Demonstrate that there is sufficient clinical data to meet the safety and performance requirements of the device
- Identify residual clinical risks and determine whether post-market clinical follow-up is required
- Maintain and update clinical evaluation documentation throughout post-market product lifecycle
What is included?
- A loan copy of the standard for use during the course
- Gain comprehensive training notes
- Gain an internationally recognized BSI Training Academy certificate
Prior knowledge and learning
- Familiarity with own device clinical safety and performance issues
- Awareness of:
Essential Requirements (Annex I) and Clinical Evaluation (Annex X) of the European Medical Device Directive or Essential Requirements (Annex 1) and Clinical Evaluation (Annex 7) of the European Active Implantable Medical Device Directive
MED DEV 2.7.1 or GHTF guidance document SG5/N2R8
Future recommendations
- Lead Auditor: ISO 13485 training course - Review ISO 13485 and build on the principles of process auditing in accordance with quality management system standards. Work with our training experts to understand the entire audit process at lead level from planning, to managing and reporting on audit results
- Medical Devices Risk Management: ISO 14971 training course - Our ISO 14971 risk management training is an essential element for all medical device manufacturers. You will learn how to identify, evaluate and control risks associated with medical devices throughout the product lifecycle, helping you implement a risk management framework to achieve ongoing compliance.
