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Summary of Safety and Clinical Performance

Summary of Safety and Clinical Performance is to provide health care workers with:

 

(a) summary of the clinical evaluation results of all the available clinical data related to the device,
(b) provide information about the device’s safety and performance, which includes the clinical benefits and the success rate for achieving the intended outcomes,
(c) inform patients of residual risks and side effects with Class III and implantable devices intended to be used directly by the patient.

Contents in Summary of Safety and Clinical Performance.

  • The identification of device and manufacturer, including the Basic UDI-DI (Unique Device Identification – device identifier) and the SRN (single registration number) if already issued: The first section of the SSCP shall identify the device and the manufacturer, Product identification should also contain some general information related to the device.
  • The intended purpose of the device and any indications, contraindications, and target populations: The intended purpose and indications shall be described which includes stages or severities of the pathologies, the specific medical conditions, and the specific anatomical locations or confirmation that no anatomical locations are contraindicated, as applicable. The target population shall be specified.
  • A description of the device, including a reference to previous generation 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: The description of the device shall be including its operating principles and mode of actions, Design characteristics, information of whether the device is for single use.
  • Possible diagnostic or therapeutic alternatives.
  • Reference to any harmonized standards and CS applied: A list with all applied common specifications (CS), international standards harmonized and Non-Harmonized standards, and relevant monographs of the European Pharmacopoeia shall be provided.
  • The summary of clinical evaluation as in Annex XIV in MDR and relevant information on post-market clinical follow-up: This section is intended to summarize, in a comprehensive manner, the clinical evaluation results and the clinical data forming the clinical evidence for the confirmation of conformity with relevant general safety and performance requirements, the evaluation of undesirable side-effects and the acceptability of the benefit-risk ratio.
  • The SSCP should include a statement if conformity of the device was assessed and endorsed by the NB on the basis of equivalence. If equivalence was used, then the device(s) for which equivalence has been demonstrated should be identified by name and Basic UDI-DI if available, together with the name(s) of its/their manufacturer(s)
  • All clinical investigations of the device in question, conducted before the CE marking, should be summarized.
  • Summary of other clinical data and the main findings pertaining to the device itself should be included if available. An overall summary of the clinical performance and safety should be provided, and that is supported by clinical evidence.
  • Suggested profile and training for users: The experience, education, or training of the intended users shall be described. This includes any specific mandatory training before using the device, and any updated training for continued safe use of the device.
  • Information on any residual risk and undesirable effects, warnings, and precautions.

When and where is SSCP Applicable?

  • Summary of safety and clinical performance (SSCP) set by the EU’s Medical Devices Regulation 2017/745 is applicable for implantable devices and for class III devices that are not custom-made or investigational. (Eg: All implantable devices intended to be placed in the teeth, Long-term surgically invasive devices intended to be used in direct contact with the heart, the central circulatory system, or the central nervous system)
  • The SSCP which will be validated by a notified body will be made publicly available via the EU database i.e. Eudamed, which is expected to be an important source of information for device users and health professionals. SSCP is not intended to give general advice on the diagnosis or treatment of particular medical conditions, nor replace the instructions for use (IFU) as the main document ensuring the safe use of a device, nor it will replace the mandatory information on implant cards or other documents.

The Summary of Safety and Clinical Performance is currently clinical data relating to the safety and clinical performance of the medical device collected for healthcare workers and the patients which are verified and validated by a Notified Body. The information provided in SSCP must be sourced entirely from technical documentation of the device which should be detailed, systematic, and objective.

 

  • It is useful to justify device proposed premarket and post-market studies, useful to understand the strength and the weakness of another similar device, useful to justify the risk.
  • SSCP Addresses all residual risks and undesirable side effects.
  • Easy to understand for Intended users and easily accessible to both patients and Healthcare professionals once uploaded by the Notified body on EUDAMED Site. It is data transparent and available in English as well as the language(s) of the Member State(s) where the Device is made available.
  • Summary of Safety and Clinical Performance provides an objective and balanced summary of the clinical evaluation results of all the available clinical data related to the device in question, whether favorable, unfavorable, and/or inconclusive,” among other information.