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
Risks and warnings	Residual risks and undesirable effects Warnings and precautions Other relevant aspects of safety, including a summary of any field safety Corrective action (FSCA including FSN) if applicable	How potential risks have been controlled or managed Remaining risks and undesirable effects Warnings and precautions Summary of any field safety corrective action, (FSCA including FSN) if applicable
Summary of clinical evaluation and post-market clinical follow-up (PMCF)	Summary of clinical data related to equivalent device, if applicable Summary of clinical data from conducted investigations of the device before the CE-marking, if applicable Summary of clinical data from other sources, if applicable An overall summary of the clinical performance and safety Ongoing or planned post-market clinical follow-up	Clinical background of the device The clinical evidence for the CE-marking Safety
Possible diagnostic or therapeutic alternatives		General description of therapeutic alternatives
Suggested profile and training for users	Experience, education and/or training of the intended user(s) Specific mandatory training before using the device, and any update training for continued safe use of the device.	Any required training should be described.
Harmonised standards and CS applied	A list with all applied common specifications (CS), international standards harmonised under the Medical Device Directives (2)(3) and/or the MDR, and relevant adopted monographs of the European Pharmacopoeia89 shall be provided. The year/revision of the applied CS, standard or monograph, should be listed together with information whether it was applied in full or in part. The year/revision of an applied harmonised standard or CS may change in the technical documentation for the device. However, an update of the SSCP concerning this change can wait until the next revision of the SSCP is issued.	NA
Revision history	SSCP revision number Date issued Change description Validation language In case of a SSCP on class IIa implantable or IIb implantable devices; whether the SSCP revision has been validated yet or not by the NB.	NA

The relationship between the Summary of Safety and Clinical Performance (SSCP) and the Instructions for Use (IFU)

The IFU serves as a crucial document that provides input for the SSCP. Conversely, the IFU must incorporate information relevant to the SSCP. This includes referencing the availability of the SSCP in the EUDAMED database and providing details such as the Unique Device Identifier (UDI) or any other relevant information for locating the SSCP within the EUDAMED database. Information contained within the IFU is derived from the same sources as the SSCP. In certain cases, the IFU itself may serve as a source for the SSCP if deemed appropriate.

Language requirements for Summary of Safety and Clinical Performance (SSCP) 

The SSCP must be available in the languages required by the member states where the devices are marketed, similar to the Instructions for Use (IFU). However, the SSCP must also be translated into English regardless of whether the IFUs and SSCPs are planned to be in English or not. Each language must have its own SSCP document. The Revision History of each SSCP document must indicate the language in which the Notified Body (NB) has validated the SSCP. The accuracy of all other translations must be verified by the manufacturer. The manufacturer must ensure, through their quality management system, that all translations are accurate.

Readability of Summary of Safety and Clinical Performance (SSCP) 

The Summary of Safety and Clinical Performance must be articulated in a manner that is easily understandable for the intended user and, if applicable, for the patient. Additionally, it must be publicly accessible through EUDAMED. Medical terminologies that are comprehensible to healthcare professionals may not be easily understood by patients. Therefore, the SSCP must include explanations of medical terminologies and procedures in lay language.

Summary of Safety and Clinical Performance (SSCP) and Notified Bodies

SSCP must undergo validation by a notified body (NB) and subsequently be accessible to the public through the European database on medical devices (EUDAMED).The initial draft of the SSCP must be included in the documentation submitted to the notified body responsible for the conformity assessment as outlined in Article 52. It is the responsibility of this body to validate the draft. The manufacturer is obligated to indicate on the label or in the instructions for use where the summary can be accessed.

Summary of Safety and Clinical Performance (SSCP) and EUDAMED

All SSCP documents must undergo submission to and approval by a Notified Body. Following approval, the Notified Body will proceed to upload the finalized SSCP into the European database on medical devices (EUDAMED)

It is imperative to maintain the updated status of the SSCP within EUDAMED. Whenever the Post-Market Clinical Follow-up (PMCF) evaluation report and the Periodic Safety Update Report (PSUR) undergo annual updates, the SSCP must also undergo a review. If necessary, updates should be made to ensure the accuracy and completeness of any clinical and/or safety information contained within the SSCP. During the update process, all sections of the document must be revised as required to ensure alignment with the latest version of the relevant sections of the Technical Documentation (TD) pertaining to the device.

Handling the Summary of Safety and Clinical Performance (SSCP) 

The manufacturer will allocate a unique identifier (reference number) to the SSCP, which will remain constant throughout the SSCP's lifespan within the manufacturer's management system. This reference number, when combined with the manufacturer's Single Registration Number (SRN), will enable the distinctive identification of the SSCP both in EUDAMED and across the European Union.

The SSCP serves as a comprehensive document, consolidating vital information on medical devices to facilitate informed decision-making and ensure patient safety across the EU. Compliance with regulatory requirements and diligent management of the SSCP are essential for manufacturers seeking market approval and continued success in the European market.

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References –

·       https://health.ec.europa.eu/system/files/2022-03/md_mdcg_2019_9_sscp_en.pdf

·       https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0745