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United StatesClinical Evaluation under EU MDR 2017/745 Training
Clinical Evaluation for Medical Devices Training for those looking to understand the clinical evaluation requirements under the EU MDR (2017/745).
Stay ahead in the medical device industry with our Course on Clinical Evaluation for EU MDR 2017/745 and MEDDEV 2.7/1 Rev. 4 compliance. Designed for regulatory and quality professionals, this course provides a practical understanding of how to meet the requirements for clinical evaluation and reporting under EU MDR.
Through interactive modules and case studies, you’ll learn to navigate clinical data collection, evaluation planning, CER preparation, and Post-Market Clinical Follow-Up (PMCF). This course equips you with the tools and knowledge to facilitate regulatory success.
Overview of our Clinical Evaluation under EU MDR 2017/745
What's covered on our Clinical Evaluation Training
Attend live, instructor-led workshops emphasizing practical, real-world application.
- Overview of EU MDR 2017/745 and MEDDEV 2.7/1 Rev. 4
- Importance of Clinical Evaluation in medical device lifecycle
- Key definitions
Practical Workshop Identify Clinical Evaluation Requirements for a Medical Device
- Requirements under EU MDR 2017/745
- Harmonization with MEDDEV 2.7/1 Rev. 4
- Role of Notified Body
Practical Workshop Assessing Compliance with EU MDR Clinical Evaluation Requirements
- Acceptable clinical data sources
Practical Workshop Evaluating the Adequacy of Clinical Data
- Purpose and Structure of a CEP
- Outlining objectives and methodology
- Identifying data sources and selection criteria
Practical Workshop Development/Review of a PMS Plan
- Components of a CER
Practical Workshop Development/Review of a CER
- Integration of PMCF into Clinical Evaluation
- Developing a PMCF plan and report
- Continuous data collection and risk management
Practical Workshop Designing a PMCF Plan
Michelle Keane
On completion of this course, successful Learners will have the practical knowledge to support their overview of Clinical Evaluation and apply the techniques needed to:
- Define the requirements for clinical evaluation under EU MDR 2017/745.
- Explain the role of MEDDEV 2.7/1 Rev. 4 guidance in Clinical Evaluation
- Differentiate between clinical data sources and their applicability
- Develop and Document a compliant Clinical Evaluation Report (CER)
- Clinical Evaluation and Post-Market Clinical Follow-up (PMCF)
Prior to attending this course, learners are expected to have the following prior knowledge:
EU MDR 2017/745
- Familiarity with the structure and key provisions of the EU Medical Device Regulation 2017/745.
- Basic knowledge of medical device classification and conformity assessment procedures under EU MDR.
MEDDEV 2.7/1 Rev. 4
- Familiarity with MEDDEV 2.7/4 Rev. 4
- Quality Professionals
- Quality Engineers
- Regulatory Professionals
Successful completion will entitle each Learner to receive a digital Certificate of Completion within 1 business day.
In order to successfully complete this course, each Learner will need to:
- Fully attend the Live Instructor Workshop as 100% attendance is required
For the live workshops during a virtual delivery, we utilize Microsoft Teams and SharePoint.
Learners need to individually have:
- PC or MAC Computer
- Reliable Internet
- Video Webcam
- Headset or Earbuds
- Quiet Setting
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What Our Learners Are Saying
4.8
Average Rating
9 global ratings
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I have completed several training courses with Comply Guru and always find them to be well structured with excellent delivery from knowledgeable instructors.
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Appreciated the well prepared training, which was very helpful to get the team subsequently introduced into our own CER process.
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Very informative. The instructor was very engaging and knowledgeable.
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Excellent training. A lot covered over 1 day.
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Trainer was very knowledgeable and open to answering questions throughout the training. the trainer gave very good information to support the requirements of Clinical evaluation Reports.
