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How to Compile the Summary of Safety and Clinical Performance (SSCP) for Medical Devices VIRTUAL WORKSHOP

Level:
Foundation
Area:
Medical Devices
Code:
MDF7
Duration:
03:00:00
Workshop profile:
This workshop is intended for participants wishing to learn about the requirements, the content and structure, input documents, and review cycles of the Summary of Safety and Clinical Performance (SSCP) for medical device. Basic knowledge of the Medical Devices Regulation 2017/745 is required.
Objective:
The Medical Devices Regulation 2017/745 (EU MDR) introduced a new document – the Summary of Safety and Clinical Performance (SSCP) – to provide access to safety and performance data to the public. Medical writers are essential to support manufacturers in writing structured and clear SSCPs for both healthcare professionals and lay persons. The SSCP requires input from several parts of the technical documentation and is subject to predefined review cycles. This workshop will give you profound insights into the regulatory requirements for the SSPCs, best practice recommendations on how to draft your first SSCPs, as well as tips and tricks on writing for a lay audience.
Content:
The course includes the following topics: - Regulatory framework: Article 32 of the EU MDR 2017/745 - Structure and Content - The MDCG (Medical Devices Coordination Group) Guidance on SSCPs (2019-9) - Input documents and review cycles - How to summarize safety and performance data for the SSCP - Differences between the healthcare professional and lay person section The workshop will include exercises, group discussions, and best practice tips.