MDCG Releases Updated SSP Guidance
Manufacturers of In Vitro Diagnostic Medical Devices in Europe must take note of Revision 1 of the MDCG 2022-9 guidance document recently issued by the Medical Device Coordination Group (MDCG). This revision brings significant changes to the Summary of Safety and Performance (SSP) template for IVDs, reflecting the evolving landscape shaped by Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).
The latest update emphasizes the importance of staying abreast of regulatory requirements as the industry navigates the complexities of the IVDR. Notably, manufacturers of class C and D devices, excluding those for performance studies, are now mandated to prepare an SSP under the IVDR. This document holds paramount importance, as it requires validation by a notified body (NB) and subsequent publication on the European database on medical devices (Eudamed).
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Here’s a Closer Look at the Key Revisions Outlined in the Updated Guidance:
✔️ Enhanced Clarity: The revision provides clearer guidelines on the availability of the SSP to patients. For devices not intended for self-testing, manufacturers have the option to include a separate patient-friendly section. Conversely, for self-testing devices, the entire SSP must be comprehensible to lay users.
✔️ Improved Terminology: The document introduces the term “intended purpose and other indications” to replace “intended use of the device,” enhancing clarity and precision in defining device functionality.
✔️ Streamlined Information: To facilitate easier reference, the indication of whether a device is for near-patient testing or serves as a companion diagnostic has been relocated within the SSP template.
These updates underscore the commitment to ensuring transparency, accessibility, and safety in the realm of in vitro diagnostic medical devices. By adhering to the latest guidance and regulatory mandates, manufacturers can navigate the IVDR landscape with confidence and uphold the highest standards of quality and compliance.
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Operon Strategist’s commitment to excellence and regulatory compliance empowers manufacturers to navigate the challenges posed by the IVDR with confidence and clarity. By partnering with Operon Strategist, manufacturers can streamline their compliance efforts and focus on bringing innovative medical devices to market while maintaining the highest standards of safety and efficacy.
