During this course we will explore the requirements for Clinical Evaluation which looks at three possible types of data –
- Literature searches, scoring papers and evaluating the relevancy to your technology
- Bench testing – comparing your device to others already on the market
- Clinical Investigation/ trials – performing actual trials in environments such as hospitals, home environments, etc.
We will look at the guidance documents and regulation requirements in this very vast and complex area.
In this course you will learn:
- An overview of the regulatory requirements for clinical evaluations and their importance
- Who should perform Clinical evaluation?
- Identifying areas that require support from clinical data – Determine whether or not a clinical investigation is required for their device
- Research Methodology
- Sources of data
- Analysis of data – screening and selecting
- Equivalency
- Structuring and collating the report according to 2.7.1 and GHTF/ IMDRF and the new MDR
- An understanding of what is required to successfully complete a clinical evaluation
- Demonstrate that there is sufficient clinical data to meet the safety and performance requirements of the device
- Discuss and evaluate the impact of the new Regulation on clinical evaluations and investigations to ensure you remain compliant and can manage the transition smoothly
- Examine how the clinical evaluation report is linked to post-market surveillance and risk management
- Assess post-market clinical studies for existing products and to examine how requirements will change with the new Regulation
Course Duration: 0.5 to 2 days
Module 1: Introduction – Overview of the course objectives
- Importance of regulatory knowledge in the medical device industry and clinical needs.
- Overview of the Medical Device Regulation (MDR) and other key standards with Clinical data.
Module 2: Requirements, Data Requirements and Preparation
- Understanding regulatory requirements for medical devices.
- Essential data and documentation needed for Clinical evidence.
- Preparation for regulatory submissions and approvals.
- Key stakeholders in the process.
Module 3: Safety/Performance, Report writing, The new MDR and notified body expectations
- Key safety and performance requirements under the MDR.
- Effective report writing for regulatory submissions.
- Changes and updates under the EU MDR.
- Expectations from notified bodies in terms of compliance and documentation.
- How to address safety and performance challenges.
Module 4: Post Market, Risk Management and Maintenance
- Post-market surveillance strategies and requirements.
- Risk management processes under the MDR.
- Ensuring continuous device performance post-market.
- Maintaining compliance through the product lifecycle.
Module 5: Application of MED DEV 2.7.1 and Chapter VI of the MDR via Case Studies
- Detailed exploration of MED DEV 2.7.1 and its role in the regulatory process.
- Understanding Chapter VI of the MDR related to clinical evaluations.
- Application of these concepts through real-world case studies.
Module 6: End of course assessment
- A comprehensive assessment to evaluate understanding of the course material.
- Focus on real-world application of regulatory knowledge.
- Discussion of results and feedback for continuous improvement.
This outline can be adjusted to fit the specific needs of your course, including more detail or additional modules if needed.
This will benefit those who especially want to market a medical device in EU or UK but will also be useful for FDA applications, since Clinical Evaluation is not a direct requirement for a typical FDA 510K if you are needing to do a PMA this course will also be useful.
Questions this course will answer:
- When do I consider doing clinical trials
- How much is enough?
- Who does clinical trials?
- Who manages the trials?
- Do I need approvals from an ethics committee?
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