Summary Of Safety And Clinical Performance (SSCP) for Medical Devices under European Union Medical Device Regulation (EU MDR 2017/745)

Summary Of Safety And Clinical Performance (SSCP) for Medical Devices under European Union Medical Device Regulation (EU MDR 2017/745)

The European Union Medical Device Regulation (EU MDR 2017/745) represents a significant update to the regulatory framework governing medical devices within the EU. Among its many provisions, the EU Medical Device Regulation (EU MDR 2017/745) emphasizes the requirement of Summary of Safety and Clinical Performance (SSCP) in demonstrating the safety and efficacy of medical devices. The Summary of Safety and Clinical Performance (SSCP) plays a pivotal role in ensuring transparency and accessibility of crucial information regarding medical devices in the European Union (EU).

Article 32 of the European Union Medical Device Regulation (EU MDR 2017/745) delineates the essential elements and prerequisites concerning the Summary of Safety and Clinical Performance (SSCP). This requirement applies to implantable devices and class III devices (excluding custom-made or investigational ones). The SSCP serves as a concise overview of safety and clinical performance, tailored to both intended users and, when applicable, patients. Accessible through EUDAMED, the European database on medical devices, the SSCP ensures transparency and accessibility to pertinent information.

The Summary of Safety and Clinical Performance (SSCP) is not meant to:

• Offer broad guidance on diagnosing or treating specific medical conditions.

• Supplant the instructions for use (IFU) as the primary document provided to ensure the safe utilization of a given device.

• Substitute the obligatory information found on implant cards or in any other mandatory documents.

Summary of Safety and Clinical Performance (SSCP) for patients

Implantable devices that are accompanied by implant cards for patients, as well as class III devices designed for direct patient use, must include a section containing information tailored for patients. Additionally, devices listed in EU MDR 2017/745 Annex XVI, eligible for an SSCP, must include a patient information section. However, certain implantable devices like sutures, staples, dental fillings, braces, crowns, screws, wedges, plates, wires, pins, clips, and connectors are exempt from the requirement of an SSCP for lay audiences. Software, not classified as an implantable device, is therefore exempt from the SSCP requirement.

For devices not falling within the aforementioned groups, including those listed in Annex XVI and eligible for an SSCP, manufacturers may assess whether it is relevant to include specific information intended for patients. This determination can be based on the manufacturer's evaluation of the device in question.

While the Summary of Safety and Clinical Performance (SSCP) offers patients valuable information about a medical device, it's crucial to remind them that professional medical advice remains paramount. The SSCP must incorporate clear statements reinforcing the importance of seeking professional medical guidance before using the device or making treatment decisions and is not a substitute for expertise and to never make self-directed decisions

What should be included in the Summary of Safety and Clinical Performance (SSCP)?

The SSCP should encompass both favorable and unfavorable information regarding the device, excluding promotional content, and ensuring readability.

All information within the SSCP should be derived solely from the technical documentation (TD) of the device, which includes design verification/validation reports, risk management reports/files, clinical evaluation reports, and plans and reports for post-market surveillance (PMS) and post-market clinical follow-up (PMCF).

Both the healthcare professional and patient sections of the SSCP mostly contain similar content, consisting of detailed information about the device, pre-clinical and clinical data, alternative treatment methods, as well as details on risk management and post-market surveillance activities.

Section of SSCP	Healthcare Professional	Lay Person
Device identification and general information	Device trade name(s) Manufacturer’s name and address Manufacturer’s single registration number Basic UDI-DI Medical device nomenclature description Class of device Year when the first certificate (CE) was issued covering the device Authorised representative if applicable; name and the SRN NB’s name (the NB that will validate the SSCP) and the NB’s single identification number	Device trade name Manufacturer; name and address Basic UDI-DI Year when the device was first CE-marked
Intended use of the device	Intended purpose Indication(s) and target population(s) Contraindications and/or limitations	Intended purpose Indications and intended patient groups Contraindications
Device description	Description of the device A reference to previous generation(s) or variants if such exist, and a description of the differences Description of any accessories which are intended to be used in combination with the device Description of any other devices and products which are intended to be used in combination with the device	Device description and material/substances in contact with patient tissues Information about medicinal substances in the device, if any Description of how the device is achieving its intended mode of action Description of accessories, if any