Glossary · EU medical devices: MDR
Summary of safety and clinical performance (SSCP)
Also known as: SSCP
Under the EU Medical Device Regulation (EU) 2017/745, the summary of safety and clinical performance is a public document that manufacturers of implantable and class III devices, other than custom-made or investigational devices, draw up for each device. It is validated by the notified body, made available through EUDAMED and written so that the intended user and, where relevant, the patient can understand it.
- EU
- MDR
- IVDR
- Technical documentation
In one sentence
The SSCP (MDR Article 32) is a public, notified-body-validated summary of safety and clinical performance for implantable and class III devices.
Example
A manufacturer of a class III breast implant writes an SSCP with a section for surgeons and a plain-language section for patients; the notified body validates it and it is published in EUDAMED under the device’s Basic UDI-DI.
How it applies
- Content: Device and manufacturer identification (including the Basic UDI-DI and the single registration number), intended purpose, indications, contraindications and target groups, a device description, possible diagnostic or therapeutic alternatives, the harmonized standards and common specifications applied, a summary of the clinical evaluation and PMCF, residual risks, undesirable effects, warnings and precautions, and the suggested user profile and training.
- Validation: The draft is part of the documentation submitted to the notified body, which validates it before publication.
- Publication: The SSCP is made publicly available through EUDAMED; the label or IFU states where it can be found.
- Updates: New clinical data from PMCF and the PSUR are reflected in the SSCP. MDCG 2019-9 gives the structure and a template.
- Technical documentation: The SSCP must be consistent with the IFU, the risk management file and the clinical evaluation report. Contradictions between them are a common audit finding.
SSCP vs. SSP
The SSCP is the MDR document for implantable and class III medical devices. The IVDR counterpart is the summary of safety and performance (SSP) under Article 29 IVDR for class C and D devices, which summarizes the performance evaluation rather than a clinical evaluation. They have different legal bases and templates.