Reserve your spot and experience a facilitated discussion regarding solutions to your regulatory challenges. To reserve your spot you must select it during registration: Visit the website to modify your registration! Due to popular demand, space is limited to 20 people per solutions circle. There is no fee, but reservations are required. Open to paid delegates only.
Managing Director PRO-LIANCE GLOBAL SOLUTIONS GmbH
Description: The Summary of Safety and Clinical Performance (SSCP) serves as a pivotal document intended to convey essential safety information about medical devices to healthcare professionals and patients. Regulation (EU) 2017/745 dictates its creation, aiming to provide a comprehensive yet accessible resource for informed decision-making and enhanced patient safety.
However, the current approach, guided by the Medical Device Coordination Group (MDCG) guidance, has resulted in SSCPs that resemble extensive volumes rather than concise summaries. This deviation from their intended purpose raises questions about their effectiveness and whether they genuinely serve the healthcare professionals and patients they are designed for.
This session examines the regulatory framework surrounding SSCPs and critically evaluates prevailing practices influenced by MDCG recommendations and Notified Body interpretation of the guidance. We explore the challenges and limitations in producing meaningful SSCPs and discuss potential strategies to transform them into concise, reader-friendly summaries. The goal is to ensure that SSCPs fulfill their intended purpose by providing clarity and accessibility, ultimately contributing to improved medical device safety and understanding. Join in for a thought-provoking discussion on reshaping SSCPs to better align with the needs of healthcare professionals and patients in the regulatory landscape.
Learning Objectives:
Upon completion, participants will have explored strategies to condense lengthy SSCPs into concise and reader-friendly formats, ensuring that vital safety information is effectively communicated.
Upon completion, participants will better understand the intention of the regulatory requirements, allowing to better balance the document content vs. length
