The week of 8–14 June 2026 brought several relevant regulatory updates in the medical device and in vitro diagnostic (IVD) sectors. This issue of MDN focuses on three main areas: IVDR transition and notified-body coordination, FDA classification activity for IVD device types, and FDA safety postings involving respiratory and circulatory support devices.
Team-NB Publishes IVDR Application and Surveillance Transfer Agreement Template
On 10 June 2026, Team-NB published a position paper and template agreement related to the transfer of IVDR formal applications and, where applicable, the transfer of appropriate surveillance of legacy devices.
The document addresses transfer arrangements between outgoing and incoming notified bodies in the context of the IVDR transitional provisions. It is presented as an association document and does not constitute an official EU regulatory act.
The publication provides useful context on notified-body coordination for IVDR application and surveillance transfers during the transitional period.
Source: Team-NB
Reference: Team-NB Position Paper on IVDR Application and Appropriate Surveillance Transfer Agreement, 10 June 2026
FDA Classifies Two IVD Device Types into Class II with Special Controls
On 11 June 2026, the U.S. Food and Drug Administration published two final orders classifying two immunology and microbiology device types into class II with special controls.
The orders cover the Spinal Muscular Atrophy newborn screening test system and the simple point-of-care device intended to directly detect SARS-CoV-2 viral targets from clinical specimens in near-patient settings.
Both orders were published in the Federal Register on 11 June 2026 and became effective on the same date.
The orders establish codified classifications and special controls for two IVD device categories.
Source: FDA / Federal Register
Reference: 1) Classification of the Spinal Muscular Atrophy Newborn Screening Test System
2) Classification of the Simple Point-of-Care Device to Directly Detect SARS-CoV-2 Viral Targets From Clinical Specimens in Near-Patient Settings
FDA Issues Early Alert on Hamilton Medical Breathing Circuit Sets
On 8 June 2026, the FDA published an Early Alert regarding certain Hamilton Medical coaxial breathing circuit sets used with HAMILTON-C1, HAMILTON-T1 and HAMILTON-MR1 ventilators.
The notice states that certain lots may have an expiratory valve membrane that adheres to the sealing ring, potentially impairing expiratory gas flow.
According to the FDA, as of 13 May 2026, Hamilton Medical had reported four serious injuries and no deaths associated with the issue.
The alert signals FDA attention to a potentially high-risk ventilation-related device issue.
Source: FDA – Center for Devices and Radiological Health (CDRH)
Reference: Early Alert: Breathing Circuit Set Issue from Hamilton Medical
FDA Identifies Abiomed Automated Impella Controllers Correction as Most Serious Recall Type
The FDA posted a correction involving certain Abiomed Automated Impella Controllers and identified the recall as the most serious type.
According to the FDA, hardware-related issues could lead to failure to boot the controller or sudden interruption in hemodynamic support.
As of 14 April 2026, Abiomed had not reported serious injuries or deaths associated with the issue.
The correction concerns controller hardware used for Impella catheter performance and monitoring.
Source: FDA – Center for Devices and Radiological Health (CDRH)
Reference: Heart Pump Correction: Abiomed Issues Correction for Automated Impella Controllers
FDA Issues Early Alert on Baxter Volara System Patient Circuits
On 11 June 2026, the FDA published an Early Alert regarding Baxter Volara System patient circuits.
The notice describes potential air and medication leakage from the nebulizer cup during therapy, which may affect delivery of the prescribed therapy.
According to the FDA, as of 21 May 2026, Baxter had reported one serious injury and no deaths associated with the issue.
The notice concerns respiratory therapy devices used in both acute care and home-care settings.
Source: FDA – Center for Devices and Radiological Health (CDRH)
Reference: Early Alert: Positive Pressure Breathing Device Issue from Baxter
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