Learn your way around the requirements for the clinical evaluation of medical devices and the impact of the MDR and guideline documents on clinical evaluation through a regulatory overview.
Clinical Evaluation for Medical Devices
24 and 25 February 2022; 9:30 am – 12:30 pm CET
The course describes how to prepare the new requirements from a clinical perspective including the MEDDEV 2.7.4/1 on clinical evaluation and the MEDDEV 2.12/2 on post market clinic follow up and MDCG Guidance on clinical evaluation for legacy devices, equivalence, sufficient clinical data.
The training will allow participants to obtain a clear understanding of the regulatory requirements and will give hands-on insight on how to achieve compliance with respect to the changing environment and new documents to be created such as the summary of safety and clinical performance (SSCP) and periodic safety update reports (PSUR).
- Overview on Medical Devices requirements
- The MDR requirements
- Get ready to MDR from a clinical perspective
- MEDDEV 2.7/1 rev 4 and MDCG guidance on clinical evaluation
- MEDDEV 2.12/2 rev 2 on post market clinical follow up studies (PMCF)
Appropriately approach the strategic kick-off of a medical device clinical evaluation
How to Write a Clinical Evaluation Plan
01 and 03 March 2022; 2:00 pm – 5:00 pm CET
The clinical evaluation plan (CEP) describes how the clinical evaluation will be performed, including objective and measurable clinical benefits, acceptability parameters for the benefit/risk profile, determination of what will be considered ‘sufficient clinical data’, what data will be collected and how any knowledge gaps might be addressed. The CEP is regularly reviewed and updated and forms the basis of the clinical evaluation report (CER).
The aim of this course is to explore what is involved in developing the CEP, including initial literature reviews and instructions for use (IFU).
- Clinical Evaluation Plan
– How to go about the planning process
– What information to use and where to find it
– How to present the information in the CEP
– How to review and update the CEP
- State of the Art & Literature Review
– How to perform a literature review as part of clinical evaluation
– How to use this literature review in the CEP
And now? How do I get started on the Clinical Evaluation Report writing?
How to Write a Clinical Evaluation Report from the MDR Perspective
12 and 14 April 2022; 2:00 pm – 5:00 pm CEST
The clinical evaluation report (CER) is an important part of the Technical File/ Design Dossier for a medical device. The medical writer conducts the literature review and compiles the CER with input from design engineers, regulatory specialists, safety scientists and quality experts. The aim of this course is to better understand what is involved in writing a CER to Medical Device Regulation (MDR) 2017/745 standards. The webinars will focus on the increased requirements of MDR and will cover the clinical evaluation process, literature review and post-market surveillance (PMS) and benefit-risk assessment.
- The Clinical Evaluation Report
– Medical device directives, guidelines and regulations
– ISO 14155:2020 guideline
– MEDDEV 2.7/1 rev. 4 (2016) guideline
– Medical Device Regulation (MDR) 2017/745
– Medical Device Classification
– Clinical Evaluation Plan
– Clinical Evaluation Process
– Clinical Evaluation Report
– PMS Activities: MDR and MEDDEV 2.12/1 rev.8
– Periodic Safety Update Reports
– Post-market clinical follow-up: MDR and MEDDEV 2.12/2 rev. 2
– Risk Assessment
– Benefit-Risk Assessment
- Literature Review Part of CER
– Literature Review Protocol
– Literature Searches
– Current Knowledge / State of the Art
– Clinical Literature
– Literature Appraisal
– Data Extraction
– Clinical Literature Analysis
After your clinical evaluation report is ready, you need to plan post-market surveillance…
Knowing your Post-Market Clinical Follow-up (PMCF)
How to program the life-cycle of your device under the MDR 2017/745 requirements
17 and 19 May 2022; 9:00 am – 12:45 pm CEST
Each device (or device family) needs a specific PMCF Plan and results of PMCF activities are summarized in a PMCF Evaluation Report. These documents are subjects to predefined review cycles and depend on several other input documents. This course will give you profound insights into the regulatory requirements for PMCF, best practice advice on how to prepare PMCF Plans and Reports, as well as insights in common pitfalls and tips on how to prevent them.
- Introduction to Annex XIV Part B of EU MDR 2017/745 (Post-Market Clinical Follow-up)
- Structure and Content: The MDCG (Medical Devices Coordination Group) Guidance on PMCF Plans (2020/7)
- Input documents and review cycles
- General and specific methods for PMCF
- Structure and Content: The MDCG (Medical Devices Coordination Group) Guidance on PMCF Evaluation Reports (2020/8)
- Practice with a fictional medical device
- Common pitfalls and strategies to avoid them
Final steps… prepare to go public with a summary of your clinical evaluation!
The Summary of Safety and Clinical Performance (SSCP)
Tools and techniques to help you in balancing regulator’s expectations and manufacturers timelines
21 and 22 June 2022; 9:00 am – 12:45 pm CEST
To be able to work on your SSCP you need strong technical skills, but you also have to be able to translate the technical documentation into a language that is clear to a lay audience without any medical background. In addition, consistency with the Technical Documentation, different expectations from the manufacturer and the Notified Body and strict timelines are additional hurdles. This course will give you profound insights into the regulatory requirements for the SSCP, best practice advice on how to prepare the SSCP, as well as insights in common pitfalls and tips on how to prevent them.
- Introduction to Article 32 of EU MDR 2017/745 (Summary of Safety and Clinical Performance)
- Structure and Content: The MDCG (Medical Devices Coordination Group) Guidance 2019/9
- Input documents and review cycles
- How to provide relevant information for healthcare professionals
- How to summarize safety and performance data from different source documents
- How to write for a lay audience
- Best practice – data visualization