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MDR & IVDR Proposed Revisions Published on 02/03/2026
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The proposed updates to the MDR and IVDR are designed to enhance regulatory efficiency, foster transparency, and streamline innovation pathways for medical device manufacturers. While the shift toward digital documentation and improved regulatory communication holds promise, there are concerns about the potential reduction in oversight and its effect on patient safety. Additionally, fee reductions for smaller manufacturers could have unintended market effects. Manufacturers need to stay updated and adapt to the evolving compliance landscape and market shifts. |
Belgium, 18 FEB 2026 – Team-NB, the European Association of Medical Devices Notified Bodies, has published a new position paper (Version 1, February 16, 2026) regarding the demonstration of safety and performance for reagent devices used in combination with other equipment. The goal of this Team NB Position Paper is to harmonize Notified Body expectations for compliance with Regulation (EU) 2017 746 (IVDR). It clarifies how IVD manufacturers should validate the compatibility and performance of combined devices, including the connection systems, to ensure alignment with Regulation (EU) 2017 746.
TEAM NB POSITION PAPER PUBLISHED : KEY REGULATORY REQUIREMENTS
The IVDR sets specific mandates for devices intended to be used in combination with other devices or general-purpose equipment, as outlined in the Team-NB Position Paper for IVD Manufacturers:
- Annex I, Section 13.1: The entire combination must be safe and must not impair the device’s performance.
- Annex I, Section 20.4.1 (j): The Instructions for Use (IFU) must identify the equipment needed for a validated, safe combination and note any known restrictions.
- Annex II, Section 6.5 (d): Technical documentation must include proof that the device conforms to General Safety and Performance Requirements (GSPR) when connected to specified equipment.
SAFETY AND PERFORMANCE FOR REAGENT DEVICES CLOSED VS. OPEN SYSTEM EXPECTATIONS
The position paper distinguishes between different system types, each with unique validation requirements:
System Type | Definition | Validation Expectation |
Closed System | Reagent is compatible only with one specific or defined set of instruments. | A full performance evaluation is required for at least one claimed combination. Equivalence must be demonstrated for additional combinations. |
Open System | Reagent can be used with similar general laboratory equipment from any brand. | The manufacturer must define the critical characteristics and specifications the lab equipment must possess. |
WHAT THIS MEANS FOR IVD MANUFACTURERS
To ensure a successful submission, manufacturers must prioritize the following in their Technical Documentation:
- Comprehensive Risk Assessment: Identify all hazards associated with combinatorial use, including operating conditions and maintenance.
- Traceable Performance Data: Provide reproducible results showing the system meets predefined acceptance criteria for all claimed combinations.
- Labeling Clarity: Ensure the IFU contains sufficient functional details for correct user integration and unambiguous warnings regarding compatibility.
- Post-Market Monitoring: Continuously monitor the safety and performance of claimed workflows and update labeling based on user feedback or new risks.
CONCLUSION
In conclusion, IVD manufacturers must ensure their technical documentation aligns with the updated IVDR requirements for combinatorial use. This includes providing thorough risk assessments, clear labeling, and traceable performance data to validate device compatibility. Manufacturers should also maintain ongoing post-market monitoring to address potential risks and ensure continued compliance with regulatory standards.