IVD manufacturers of highest risk classes shall be informed of an important template endorsed by the MDCG: 2022-9 the Summary of safety and performance Template.
According to Article 29 of IVDR 2017/746, the manufacturers of Class C and D devices, with the exception of devices for performance studies, shall prepare a summary of safety and performance (SSP) that is clear to the intended user (and the patient). The SSP should be provided to a notified body, which validates the document, and uploads it to EUDAMED, where it becomes available to the public. Moreover, the manufacturers shall indicate the location of the SSP on the device label or IFUs.
The MDCG document on the SSP consists of two sections. In the first section, there is the template for the devices not intended for self- testing. For these devices, the first part of the SSP should be relevant for the professional users and the second part for the patients/lay persons. The second section of the guidance constitutes the template for self-testing devices, which should be presented in a comprehensive way to the patients/ lay persons.
The template for non-self-testing devices consists of the following information:
1. The part intended for the professional users should include:
• Document revision
• Date issued
• Manufacturer’s reference number for the SSP
• Sections for:
-
- Device identification and general information
- Intended use of the device
- Device description
- Reference to any harmonised standards and CS applied
- Risks and warnings
- Summary of Performance Evaluation and post-market performance follow-up (PMPF)
- Metrological traceability of assigned values
- Suggested profile and training for users
- Revision history (a template is provided)
- In the part directed to the patients/lay persons, sections should cover:
- Document revision
- Date issued
- Device identification and general information
- Intended use of the device
- Device description
- Risks and warnings
- Summary of Performance Evaluation and post-market performance follow-up
- Suggested profile and training for users
In the template for self-testing devices there is only one section for patients/lay persons and the manufacturer should insert the following information, as well as some additional text including in the MD:
- Document revision
- Date issued
- Manufacturer’s reference number for the SSP
- Sections for:
- Device identification and general information
- Intended use of the device
- Device description
- Reference to any harmonised standards and CS applied
- Risks and warnings
- Summary of Performance Evaluation and post-market performance follow-up (PMPF)
- Metrological traceability of assigned values
- Suggested profile and training for users
- Revision history (a template is provided)
You can find the full text of the MDCG document in our dedicated Library – MDCG – IVDR.
References:
MDCG 2022-9 (May 2022). Summary of safety and performance Template. Retrieved on 24.05.2022 from https://ec.europa.eu/health/latest-updates/mdcg-2022-9-summary-safety-and-performance-template-2022-05-20_en
European Parliament and Council of the European Union (2017). Regulation (EU) 2017/746 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU. Retrieved on 24.05.2022 from https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0746.
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