25 September 2023
PRE-CONFERENCE WORKSHOP

From 13:30 to 17:30 | NH Vienna Airport, Vienna

From Good to Excellent: The Summary of Safety and Clinical Performance (SSCP)
An advanced training to improve your SSCP and write it in the most efficient way


Introduction
The Summary of Safety and Clinical Performance (SSCP) is a document that is with a unique structure and format: it is intended to include detailed information on a medical device for both healthcare providers and patients and will be available for the public. Many manufacturers already know how to write an SSCP.

We also have read MDCG 2019-9, but how can we go from good to excellence? And how can we improve a document which will be public soon?
To be able to work on your SSCP you need strong technical skills. You also have to be able to translate the technical documentation into lay language: Are we complying with a regulatory requirement or are we really communicating with the public?
Consistency with the Technical Documentation, different expectations from the manufacturer and the Notified Body and strict timelines are additional hurdles.

This workshop will navigate you through the needed skills to achieve excellence and positively impact the final document.

Programme

  • 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
  • How to optimize input documents for more efficient SSCP writing
  • Best practice tips to summarize safety and performance data
  • How to improve the patients’ section of the SSCP

Who should attend?
The workshop is addressed to Clinical Affairs, Quality Assurance, Product Managers and Medical Writers.

Participant experience
This workshop is intended for personnel with little experience in regulatory writing, including the Summary of Safety and Clinical Performance, under the Medical Devices Regulation 2017/745 (EU MDR) and with little experience in the preparation of lay summaries.

Teaching methods
The workshop will be a mixture of presentations, team discussion, brainstorming and practical examples.

Lecturer

Dr. Katharina Friedrich, MD – Freelance Medical Writing Consultant
Katharina Friedrich is a medical writer with 5 years of experience in MDR regulatory writing. She is based in Heidelberg, Germany and works as a Freelance Medical Writing Consultant for various medical device companies, including startups and global players. She prepares Clinical Evaluation Plans and Reports, PMCF Plans and Reports and SSCPs in compliance with MDR 2017/745 for class I to class III devices. She also supports development projects and the conduction of PMCF activities. As medical doctor she has experience in the field of orthopedic, spine and trauma surgery and intensive care medicine.

At the end of the training, you will be able to:

  • Understand the regulatory requirements for the SSCP
  • Optimize the relevant input documents for the SSCP and learn how to extract the most relevant information
  • Prepare lay summaries, including product description and summary of study results
  • Prepare a summary of safety and performance information for healthcare professionals
  • Understand common pitfalls with the preparation of the SSCP and know how to avoid them
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