We simplify market access for medical devices

ISO

ISO/TS 24971-2:2026 Medical devices — Guidance on the application of ISO 14971 / Part 2: Machine learning in artificial intelligence has been published.

• Provides guidance on risks specific to ML and on applying the ISO 14971 risk management process to ML-enabled medical devices (MLMD)
• Topics: data management, feature extraction, unwanted bias, information security, ML model training, evaluation and testing of the trained ML model

European Commission

MDCG 2026-5 UDI assignment between manufacturers and distributors has been published.

• Only the manufacturer can assign UDIs and receive codes from EU UDI issuing entities, even when the same device is marketed under two different brand names
• Delegation of UDI assignment to a third party via contract is permissible; legal responsibility for UDI compliance remains with the manufacturer
• ARs, distributors, and importers may not assign UDIs to devices

Swissmedic

A new Information Sheet on swissdamed registration fee is published, outlining the details of basic fee, unit fee and billing information that had been originally posted, albeit in a less detailed manner, on Swissmedic’s bespoke webpage. 

European Commission

An updated List of Notified Bodies’ standard fees has been published. The document merely lists hyper links to the corresponding Notified Body’s website. 

Swissmedic

A new version of swissdamed User Guide for UDI registration (V.4) has been published. A new chapter 12 is added, outlining the guidance of swissdamed registration for legacy devices, including EUDAMED DI, EUDAMED ID, and the link between regulation and legacy devices.

Team NB

Position paper of Proposal for risk adaptive surveillance system (EU MDR) is published. 

• Aligned Surveillance Model: Mirrors the IVDR proposal by establishing a three-tier risk-adaptive surveillance system for medical devices to determine audit frequency and intensity
• Well-Established Technology (WET): Introduces strict criteria for WET devices, defining them as devices with standard designs, predictable performance, and a long, continuous history of safe clinical use on the market.
• PSUR Adjustments: Establishes new PSUR update requirements and timelines for Class IIa, IIb, and III medical devices.
• Strict Equivalence Rules: Prevents the “chaining” of equivalence claims by explicitly prohibiting a device from claiming clinical equivalence to a device that also achieved its status via an equivalence claim

Position paper of Proposal for risk adaptive surveillance system (IVDR) is published. 

• Surveillance Overhaul: Proposes eliminating the maximum validity period for certificates, replacing recertification with periodic reviews based on device and manufacturer risk.
• Three-Tier System: Classifies manufacturers into initial/enhanced, medium, or reduced surveillance levels, which dictates the frequency of unannounced audits and technical documentation sampling.
• Reporting & Testing Updates: Adjusts the update schedules for Periodic Safety Update Reports (PSUR) for Class C and D devices, and allows EU Reference Laboratory (EURL) batch testing frequencies to be adjusted based on the assigned risk level.
• Clinical Equivalence: Clarifies that manufacturers must provide sufficient, clear data to justify claiming clinical equivalence to an existing diagnostic device.