Europe Regulatory ServicesThe Summary of Safety and Clinical Performance (SSCP) is a regulatory requirement under Regulation (EU) 2017/745 (EU MDR) for Class IIb implantable medical devices and Class III medical devices, excluding custom-made and investigational devices. The manufacturer is responsible for preparing the SSCP, which must be validated by the Notified Body and made publicly accessible through EUDAMED.
The SSCP provides transparent and accessible information on the device's safety and clinical performance, including a summary of relevant clinical data and other pertinent information. It serves as an important source of information for healthcare professionals and, where applicable, patients, supporting informed understanding of the device's clinical benefits, safety profile, and performance.
Our Services Include
- SSCP Preparation as per MDCG 2019-9 Rev. 1.
- SSP Preparation as per MDCG 2022-9 Rev. 1.
- Technical Documentation Review and Data Compilation.
- Clinical and Performance Evidence Summarization.
- Risk, Safety, and Warning Information Assessment.
- SSCP/SSP Revision and Maintenance.
General requirements for the SSCP and SSP
- The information presented in the Summary of Safety and Clinical Performance (SSCP) and Summary of Safety and Performance (SSP) shall be derived from the device’s Technical Documentation (TD), including design verification and validation reports, the Risk Management File, Clinical Evaluation Report (CER), and Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF) plans and reports. The Instructions for Use (IFU), which is based on the same technical evidence, may also serve as a source for the SSCP where appropriate.
- The manufacturer shall assign a unique reference number to the SSCP or SSP within its document management system. This identifier shall remain unchanged throughout the SSCP’s or SSP’s lifecycle and, together with the manufacturer’s Single Registration Number (SRN), enable unique identification of the SSCP or SSP within EUDAMED and the European Union.
- The SSCP or SSP shall be maintained and updated in EUDAMED as necessary. Any revision shall consider all relevant sections of the SSCP or SSP to ensure consistency with the latest applicable information contained in the device’s Technical Documentation.
Contents of SSCP for Medical devices MDCG 2019-9 rev.1
- The identification of the device and the manufacturer, including the Basic UDI-DI and, if already issued, the SRN
- The intended purpose of the device and any indications, contraindications and target populations.
- A description of the device, including a reference to previous generation(s) or variants if such exist, and a description of the differences, as well as, where relevant, a description of any accessories, other devices and products, which are intended to be used in combination with the device.
- Information on any residual risks and any undesirable effects, warnings and precautions.
- The summary of clinical evaluation as referred to in Annex XIV, and relevant information on post-market clinical follow-up.
- Possible diagnostic or therapeutic alternatives
- Suggested profile and training for users
- Reference to any harmonised standards and CS applied
- Revision history
Contents of SSP for IVD Medical devices MDCG 2022-9 Rev.1
- Device identification and general information
- Intended purpose and other indications
- Device description
- Reference to any harmonised standards and CS applied
- Risks and warnings
- Summary of performance evaluation and post-market performance follow-up (PMPF)
- Metrological traceability of assigned values
- Suggested profile and training for users
- Revision history
We support medical device and IVD manufacturers in preparing and maintaining compliant SSCP and SSP documentation under EU MDR 2017/745 and EU IVDR 2017/746.
