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
    27 and 29 September 2021
    9:30 am – 12:30 pm CEST  (2 modules of 3 hours each, 6 hours in total)
    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).
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Appropriately approach the strategic kick-off of a medical device clinical evaluation

  • How to Write a Clinical Evaluation Plan
    05 and 07 October 2021
    2:00 pm – 5:00 pm CEST  (2 modules of 3 hours each, 6 hours in total)
    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).
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And now? How do I get started on the Clinical Evaluation Report writing?

  • How to Write a Clinical Evaluation Report from the MDR Perspective
    19 and 20 October 2021
    2:00 pm – 5:00 pm CEST  (2 modules of 3 hours each, 6 hours in total)
    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.
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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
    09, 11 and 15 November 2021
    9:30 am – 12:00 pm CET  (3 modules of 2,5 hours each, 7,5 hours in total)
    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.
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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
    29 November, 01 and 03 December 2021
    10:00 am – 12:00 pm CET  (3 modules of 2 hours each, 6 hours in total)
    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.
    See full programme here
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