Team-NB – MDR Certification Process Consensus Document V2.1

Summary
Team-NB has published version 2.1 of the consensus document on the MDR certification process. The document describes the pre-application, application, and post-application phases, with reference to both legacy devices and new devices to be placed on the market. The goal is to harmonize the approach of Notified Bodies and make the MDR certification process more predictable.

Practical Impact
High priority for manufacturers undergoing initial MDR certification, Notified Body (NB) transfer, or renewal. It is recommended to compare your application package checklist with Team-NB’s expectations to ensure its completeness.

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Team-NB – MDR Proposal for a Risk-Adaptive Surveillance System

Summary
Team-NB proposes a risk-adaptive surveillance model for MDR devices. The proposal covers activities such as surveillance audits, unannounced audits, and sampling of technical documentation, with intensity and frequency that can be adjusted based on risk and the manufacturer’s performance. The proposal ties into the debate on the evolution of the certification system and the possible replacement of certain periodic mechanisms with risk-proportionate reviews.

Practical Impact
This is not a binding document, but it may foreshadow future expectations. Manufacturers should strengthen their PMS indicators, CAPA management, trend analysis, PSURs/PMSRs, audit readiness, and change control, as these elements could influence the intensity of surveillance.

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Team-NB – IVDR Proposal for a Risk-Adaptive Surveillance System

Summary
Team-NB proposes a risk-adaptive surveillance model for IVDR devices. The document identifies potential factors that could lead to an increase or decrease in the intensity of surveillance, including serious incidents, FSCA, non-compliance, ineffective CAPA, PMS indicators, delays or critical issues in PSURs/PMSRs, and trends.

Practical Impact
Relevant for certified IVD manufacturers or those transitioning to the IVDR. It is recommended to strengthen PMS/PMPF systems, trend management, PSURs, performance evaluation, CAPA, and audit readiness, as the quality of the post-market system may become increasingly critical for surveillance.

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