Team-NB has published a new guidance document outlining harmonised Notified Body expectations for demonstrating the safety and performance of reagent devices intended for use in combination with other devices, equipment, or instruments.
The document clarifies key considerations for ensuring compliance with Regulation (EU) 2017/746 (IVDR). It is intended to support and complement the existing Team-NB Position Paper: Best Practice Guidance for the Submission of Technical Documentation under Annex II and III of In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746.
Scope and Key Expectations
The guidance sets out expectations for manufacturers in the following areas:
- Compatibility and combined use – Clear demonstration that reagent devices function safely and perform as intended when used in combination with specified devices or systems.
- Connection systems – Where applicable, appropriate validation of physical and/or digital interfaces between components.
- Risk assessment – Comprehensive identification and mitigation of risks arising from combined use, including foreseeable misuse.
- Performance evaluation – Adequate data to substantiate analytical and clinical performance in the intended combined configuration.
- Information supplied to users – Clear instructions and limitations to ensure safe and effective use in practice.
Overall, the document aims to promote consistent regulatory expectations across Notified Bodies while supporting manufacturers in preparing robust technical documentation for combination reagent devices under the IVDR framework.
The full position paper can be accessed using the following link
