SSCP Under the EU MDR: Requirements, Review and Translation Considerations
A practical webinar for medical device regulatory and clinical affairs professionals
The Summary of Safety and Clinical Performance (SSCP) is a key part of the EU Medical Device Regulation (MDR), providing patients and healthcare professionals with accessible information about the safety and clinical performance of certain medical devices.
Preparing an SSCP requires more than assembling clinical and technical information. Manufacturers must understand the applicable regulatory requirements, ensure the summary is consistent with the supporting documentation, and communicate complex information appropriately for different audiences.
Join Morningside and Mantra Systems for a practical, 45-minute webinar exploring the SSCP requirements, common preparation challenges, and the role of accurate life sciences translation in supporting multilingual medical device documentation.
What you’ll learn
- Why SSCPs exist: Understand their purpose as a public-facing summary of device safety and clinical performance.
- Which devices require an SSCP: Review the applicable requirements for implantable and Class III devices, including relevant exclusions.
- The regulatory framework: Explore MDR Article 32, Annex XIV, and MDCG 2019-9 Rev.1.
- What an SSCP must contain: Walk through the required content and key considerations for preparing a compliant summary.
- How the SSCP fits into the technical documentation: Understand why the summary must accurately reflect the underlying clinical and technical evidence.
- Patient and healthcare professional versions: Examine how information, language, and presentation should differ for each audience.
- Translation and multilingual documentation: Consider the importance of terminology consistency, contextual accuracy, and audience-appropriate communication across languages.
- Common mistakes and practical takeaways: Identify potential challenges and leave with considerations to support your SSCP preparation and review process.
When
November 10, 2026 9:45AM – 10:45AM
Meet the speakers
Dr. Gayle Buchel, (MBChB), Chief Medical Writer
Dr. Gayle Buchel will walk through the SSCP regulatory framework, required content, relationship to the technical documentation, and practical considerations for manufacturers, including common mistakes and key takeaways.
Dr Gayle Buchel is a medical doctor with 17 years of clinical experience, including 7 years running her own practice. For the past five years she has worked in medical device regulation and is now Chief Medical Writer at Mantra Systems, where she leads clinical evaluation work across every MDR risk class. She has written and reviewed SSCPs for implantable, Class III hardware and software devices, drawing on her clinical background to turn complex clinical evidence into clear, accurate summaries for patients and clinicians.
Anna Eisenberg, Director Life Sciences Business Development
Anna will discuss how life science translation supports the preparation of multilingual medical device documentation, with a focus on accuracy, terminology consistency, and communication for patients and healthcare professionals.
Anna Eisenberg is the Director of Life Science Business Development at Morningside, with 20+ years of experience in the localization industry and a focus on life sciences. She is responsible for Morningside’s life science strategy and maintaining relationships with global leaders in the field. Anna expertly advises pharmaceutical and medical device companies on best translation practices and is an expert in implementing workflows that improve quality, reduce costs, and accelerate deadlines.
