The summary of safety and clinical performance (SSCP) shall be laid out with an objective of it being easy for the intended user to interpret and, if relevant, to the patient. It shall be made available to the public via Eudamed. Along with all the other technical documents, the draft of the summary of safety and clinical performance shall also be submitted to the notified body involved in the conformity assessment and shall be validated by that body. After its authentication, the notified body shall upload the summary to Eudamed. The manufacturer shall mention all the information relevant to access this summary on the label or instructions for use.
The objective of summary of safety and clinical performance (SSCP) is not to:
provide advice on the diagnosis or treatment of particular medical conditions, nor
replace the instructions for use (IFU) as the main document that will be provided to ensure the safe use of a particular medical device, nor
replace the obligatory information on implant cards or in any other mandatory documents.
To which devices summary of safety and clinical performance (SSCP) will be applicable and when to update?
The manufacturer shall draw up a summary of safety and clinical performance for implantable devices and for class III devices, other than custom-made or investigational devices.
For class III devices and class IIb implantable devices, other than sutures and staples etc., submit a draft summary of safety and clinical performance (SSCP) which has been updated within 12 months, regardless of whether there are new data or conclusions.
For class IIa implantable and IIb implantable devices, such as sutures, confirm that the SSCP in EUDAMED is in alignment with the current version of the Technical Documentation (TD), or provide an updated SSCP where required.
Update of the summary of safety and clinical performance (SSCP) at least annually as indicated
The identification of the medical device and the manufacturer, including the Basic UDI-DI and, if already issued, the Single Registration Number (SRN)
The intended purpose of the device and any indications, contraindications and target populations
A description of the medical device, including a reference to previous generation(s) or variants and a description of the differences, as well as, where applicable, a description of any accessories, other devices and products, which are intended to be used in combination with the medical device
Possible diagnostic or therapeutic alternatives
Reference to any harmonized standards and Common Standards (CS) applied
The summary of clinical evaluation as referred to in Annex XIV in Regulation (EU) 2017/745, and relevant information on post-market clinical follow-up
Suggested profile and training for users
Information on any residual risks and any undesirable effects, warnings and precautions
For implantable devices and class III devices, other than custom-made or investigational
devices, the manufacturer shall draw up a summary of safety and clinical performance (SSCP)
SSCP should update annually as indicated in Regulation (EU) 2017/746
Yes. It is available on EUDAMED and on IFU/label, the manufacturer will mention the
details where SSCP is available