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Every device undergoes a unique journey of unlocking access to the European Union (EU) market, tailored to its specific type, risk class, and other factors. Navigating this path involves achieving key mandated documents as part of the approval process. A crucial element in this process is the Summary of Safety and Performance (SSP), which ensures that your In Vitro Diagnostic (IVD) devices meet the highest standards of safety and performance for a successful market entry.

What is an SSP?

The EU In Vitro Diagnostics Regulation (IVDR) 2017/746 mandates Class C and D IVD manufacturers to prepare a document comprising a summary of the safety and performance of the devices intended to be placed on the market. The SSP is publicly available document for patient, users and healthcare professionals which includes general information about the device, summary of the performance data and possible therapeutic alternatives.

What is the Objective of an SSP?

The aim of an SSP within the EU IVDR is to offer the public an updated overview of the primary safety and performance features of IVD devices. This summary is customized for the intended user and, if applicable, to the patient, thus ensuring clarity for laypersons. Validation by a Notified Body (NB) is mandatory, and the SSP must be accessible through the European Medical Devices Database (EUDAMED).

It functions as a crucial resource for educating patients and users on the fundamental safety and performance aspects of IVDs; in fact, the SSP complements the Instructions for Use (IFU) instead of replacing it.

What are the Key Requirements for Drafting an SSP?

The IVDR SSP documentation should include some basic details, which are outlined below:

  • Device Identification and General Information
  • Intended Purpose
  • Device Description
  • Inclusion of Relevant Harmonized Standards and Common Specifications
  • Summary of Performance Evaluation
  • Summary of Post-market Performance Follow up (PMPF)
  • Risks and Warnings
  • Metrological Traceability of Assigned Values
  • Suggested Profile and Training for Users
  • Revision History

In addition, all SSPs must include a separate section for patients/laypersons and healthcare providers/professionals. Also, the Medical Device Coordination Group (MDCG) guideline document provides a template for SSP for devices that are intended for self-testing and SSP for devices not intended for self-testing.

What are the Implications of an SSP?

The IVDR SSP documentation plays several key roles during the lifecycle of IVDs. It provides transparency to patients, healthcare professionals, and other stakeholders, aiding them in making informed decisions. It focuses on clarity and easily comprehensible language, so that it can cater to both professional users and laypersons.

An SSP serves as a key communication tool for manufacturers, users, and Regulatory authorities, helping them ensure accurate safety and performance information on IVDs. Moreover, the continuous updates on the EUDAMED reflect any changes or new findings regarding device safety and performance.

Lastly, an SSP plays a crucial role in Post-marketing Surveillance (PMS) requirements, necessitating periodic updates based on post-market data for the ongoing monitoring of device safety and performance.

We recognize that navigating these complex requirements can be challenging, particularly with multiple product lines. Our dedicated team of seasoned experts will aid you in every aspect of the market approval process. While you focus on advancing healthcare, we will ensure that your devices reach the market seamlessly! Contact us today to learn how we can streamline your path to compliance.