Summary of Safety and Clinical Performance
21 May 2026 2026-05-21 16:13Summary of Safety and Clinical Performance
Summary of Safety and Clinical Performance
| What is SSCP? |
| The Summary of Safety and Clinical Performance (SSCP) is a requirement of the EU Medical Devices Regulation (EU MDR). SSCP provides a summary of the risks and benefits of certain devices and must be provided for all Class III and implantable devices (other than custom-made or investigational devices) and will be available in EUDAMED. The IFU shall contain all that is needed to directly find the SSCP in EUDAMED. |
| Purpose of SSCP |
| The SSCP allows public access to an updated summary of clinical data and other information about the safety and clinical performance of the medical device. The SSCP will be an important source of information for intended users – both healthcare professionals’ (HCPs) and, if relevant, for patients. It is one of several means intended to fulfill the objectives of EU MDR to ensure a robust, transparent, and sustainable regulatory framework and maintain a high level of safety. |
| SSCP Contents |
| The SSCP contains easily understood and relevant information for HCPs and, when relevant, the public. This information is presented in separate sections and uses language and terms appropriate for the respective audience. Key information captured in the SSCP includes the description and intended use of the devices in scope, associated risks and warnings, an objective summary of existing and planned clinical data, and possible diagnostic or therapeutic alternatives. The SSCP is updated continuously through the products life cycle as new clinical data or other relevant information is available. |
| Accessing the SSCP |
| After review and approval by a Notified Body, it is the Notified Body’s responsibility to upload the SSCP into EUDAMED. At the latest when EUDAMED becomes mandatory the SSCP can be obtained from the Device section of EUDAMED on ec.europa.eu/tools/eudamed. Prior to the EUDAMED mandatory usage date, the manufacturer makes the SSCP available upon request. |
| Company Name: T-BİYOTEKNOLOJİ LABORATUVAR ESTETİK MEDİKAL KOZMETİK SAN. TİC. LTD. ŞTİ. |
| Actor ID/SRN: TR-MF-000016403 |
