Summary of Safety and Performance (SSP)

The EU IVDR 2017/746 mandates a requirement known as the Summary of Safety and Performance (SSP) for class C and D devices. The main purpose of the SSP document’s development is to make transparent information available and allow the general public access to data regarding the performance and safety of IVDs.

SSP is a public document that must include general information about the IVD, a summary of performance data, and possible therapeutic alternatives.

• It should be written in a manner that is understandable to the intended user and, if relevant, patients, since it is a public document.
• It is not intended to replace the Instructions for Use as the main document to ensure the safe use of the device, nor it is intended to provide diagnostic or therapeutic suggestions.
• As part of the technical documentation, a draft copy of the SSP must be created and submitted to the NB. It will be validated by NB, who will check that all necessary parts are included in accordance with MDCG 2022-9 and compliance with Article 29 of EU IVDR and assess whether the SSP has incorporated all pertinent data from the technical documentation.
• The notified body will upload the summary to Eudamed following validation. Every year, the manufacturer is required to add new information to the SSP and include a notice about this on the label or usage instructions in situations where the summary is accessible.

The following points should be covered in the Summary of safety and performance as per Article 29 of EU IVDR 2017/746.

• Identification of the device and the manufacturer, including the Basic UDI-DI and, if already issued, the SRN.
• The intended purpose of the device, indications, contra-indications, and target populations.
• Description of the device, including a reference to the previous generation(s) or variants if such exist, and where relevant, a description of any accessories, other devices, and products, that are intended to be used in combination with the device.
• Reference to any harmonized standards and Common Specifications applied.
• Summary of the performance evaluation and relevant information on the PMPF.
• Metrological traceability of assigned values
• Suggested profile and training for users.
• Information on any residual risks and any undesirable effects, warnings, and precautions.

Following the MDCG 2022-9 guidance consists of two sections for preparing the SSP template as shown below.

Section-1 for the devices not intended for Self-testing, the SSP should have a first part addressed to the professional user and the second part for the end user/patient.

Section-2 for devices intended for Self-testing, The SSP should be written in a way that is understandable to the patient/layperson, for example, considering the age of the target population. It provides the complete method to the patients/laypeople.

In the context of IVDR 2017/746 CE Marking, consultants can play a significant role in assisting manufacturers with the preparation and documentation of the Summary of Safety and Performance (SSP) for their in vitro diagnostic medical devices (IVDs). The SSP is a crucial document required under the IVDR that provides essential information about the IVD, its intended purpose, performance characteristics, and safety aspects. Here’s how consultants can contribute to the preparation of the SSP:

• Write the SSP according to EU IVDR (Invitro Diagnostic Medical Device Regulation) 2017/746.
• Review your SSP.
• Resolve non-conformities identified following SSP validation by NB.