The week of 13–19 July 2026 brought several relevant regulatory developments in the medical device and in vitro diagnostic (IVD) sectors.
This issue covers updated European data on medical device availability, an updated European Commission list of notified-body standard fees, revised UK guidance on point-of-care IVD Devices, an FDA request for input on non-device software functions, and a potentially high-risk issue affecting ResMed ventilators.
In this issue
- European Commission Publishes Version 3.5 of Medical Device Availability Dashboard
- European Commission Updates Notified-Body Standard-Fee List
- MHRA Updates Guidance on Point-of-Care IVD Devices
- FDA Requests Input on Certain Non-Device Software Functions
- FDA Issues Early Alert for ResMed Astral Ventilators
European Commission Publishes Version 3.5 of Medical Device Availability Dashboard
On 14 July 2026, the European Commission published version 3.5 of the dashboard supporting its study on the availability of medical devices in the EU market.
The dashboard presents data collected from industry stakeholders and comparable information from previous Commission surveys of notified bodies. It forms part of a DG SANTE study monitoring the availability of medical devices under the EU regulatory framework.
The dashboard provides updated institutional data on device availability and conformity-assessment activity in the European market.
Source: European Commission
Reference: Study supporting the monitoring of availability of medical devices on the EU market — Dashboard version 3.5, European Commission, 14 July 2026
European Commission Updates Notified-Body Standard-Fee List
The European Commission published an updated consolidated list of links to standard-fee schedules made available by notified bodies designated under the MDR and IVDR.
The document separates MDR and IVDR services and directs users to fee information published by individual notified bodies.
Article 50 of the MDR and Article 46 of the IVDR require notified bodies to establish lists of their standard fees and make them publicly available.
The list provides a single institutional access point for tracking publicly available conformity-assessment fee schedules under the MDR and IVDR.
Source: European Commission
Reference: List of notified bodies’ standard fees, European Commission, updated 13 July 2026
MHRA Updates Guidance on Point-of-Care IVD Devices
On 14 July 2026, the Medicines and Healthcare products Regulatory Agency updated its guidance on the management and use of point-of-care testing in vitro diagnostic devices.
This revision removes outdated references, updates the section covering training and UKAS accreditation, and clarifies the scope and reporting routes for medical-device incidents across the different parts of the United Kingdom.
The guidance applies to POCT services in hospitals, outpatient clinics, community care, general practices and other primary-care settings.
The update consolidates current MHRA information on governance, training, accreditation and incident reporting for professional point-of-care testing services.
Source: MHRA
Reference: Management and use of IVD point of care test devices, MHRA, updated 14 July 2026
FDA Requests Input on Certain Non-Device Software Functions
On 14 July 2026, the U.S. Food and Drug Administration requested information on patient safety, education, professional competency and related best practices for certain software functions excluded from the statutory definition of a medical device under the 21st Century Cures Act.
The request covers software used for healthcare administration, healthy-lifestyle support, electronic patient records, data transfer or display, and limited clinical decision support.
The information will support FDA’s 2026 biennial report on the risks and health benefits of non-device software functions. Comments are due by 13 August 2026.
The process will inform FDA’s latest assessment of the patient-safety effects of healthcare software functions that fall outside medical-device regulation.
Source: FDA – Center for Devices and Radiological Health (CDRH)
Reference: FDA Requests Input on Certain Non-Device Software Functions and Impacts to Patient Safety, FDA, 14 July 2026
FDA Issues Early Alert for ResMed Astral Ventilators
On 15 July 2026, the FDA issued an Early Alert concerning certain ResMed Astral 100 and Astral 150 ventilators manufactured before October 2024.
A supercapacitor in affected devices may leak over time and damage circuitry on the printed circuit board assembly. As a result, the ventilator may enter a fail-safe state, potentially interrupting therapy or preventing ventilation from starting.
The devices are used for invasive and non-invasive ventilatory support in home, hospital and portable settings.
As of 23 June 2026, ResMed had reported five serious injuries and no deaths associated with the issue. FDA stated that replacement-component availability was constrained and that corrective activity would be conducted in phases.
FDA also stated that patients should not stop using the ventilator unless instructed by their clinician.
Therapy interruption or failure in ventilator-dependent patients may result in serious injury or death.
Source: FDA – Center for Devices and Radiological Health (CDRH)
Reference: Early Alert: Ventilator Issue from ResMed, FDA, 15 July 2026
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