Introduzione
Summary of Safety and Clinical Performance (SSCP)
The Summary of Safety and Clinical Performance (SSCP) is one of the new clinical evaluation documents required under the EU Medical Device Regulation (MDR).
Designed to provide transparent and reliable information for both healthcare professionals and patients, the SSCP will be publicly available and validated by the Notified Body.
Although many professionals have already encountered the SSCP requirements and the MDCG 2019-9 guidance, developing a compliant and effective SSCP can be challenging — especially when balancing technical accuracy, readability, and consistency with the Technical Documentation.
This introductory course provides a clear and structured overview of how to prepare the SSCP under MDR.
Participants will learn how to extract key information from clinical and technical documentation, summarize safety and performance data, and communicate findings in a way that is both scientifically sound and accessible to a lay audience.
Through examples and guided discussions, the course will help you understand the what, why, and how of the SSCP, laying the foundation for effective and compliant writing.
Programme
- Purpose of the Safety and Clinical Performance (SSCP)
- Requirements under MDR (Article 32)
- Applicable Guidances (MDCG 2019-9)
- Structure and Content of the SSCP
- Lay Section of the SSCP
Medical Writers working on clinical evaluation, Quality Assurance, Product Managers, Regulatory Affairs.
Participant experience
This workshop is intended for people with limited experience in writing the Summary of Safety and Clinical Performance.
Presentation, team discussions, practical examples.
Docente/i
Geneviève Laumen
Geneviève Laumen is a freelance Medical Writer specializing in clinical evaluation documentation for medical devices in compliance with European regulatory requirements.
She supports manufacturers in preparing Clinical Evaluation Plans and Reports, State of the Art reviews, and Summary of Safety and Clinical Performance (SSCP) documents across a wide range of device classes and therapeutic areas.
Before starting her freelance activity, Geneviève worked within the medical device industry as a Clinical Evaluation Manager, gaining hands-on experience in regulatory compliance and clinical evidence generation under the MDR framework.
She is based in Oldenburg, Germany, and collaborates with international clients to ensure high-quality, consistent, and compliant clinical evaluation deliverables.
Online Training – 1 module
22 April 2026 from 9:00 am to 1:00 pm CEST
Few days before the online training you will receive all details about the connection.
The course will proceed with a minimum number of participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.
Early Bird: € 490,00* (until 08/04/2026)
Ordinary: € 620,00*
Freelance – Individual – Academy – Public Administration: € 410,00*
* for Italian companies: +22% VAT
The fee includes: tuitions, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.
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Events & Training Manager
Cosa saprai fare dopo il corso
Online interactive training on Zoom platform.
LS Academy will provide the access link to the virtual platform a few days before the training.