The week of 1–7 June 2026 brought several relevant regulatory updates in the medical device and in vitro diagnostic (IVD) sectors. The week’s most actionable developments concerned the MDR certification pathway, the expansion of FDA’s planned 510(k) exemptions, and two safety alerts requiring attention from affected stakeholders.
As a reminder, as of 28 May 2026, the mandatory-use requirements for the first four EUDAMED modules became applicable, subject to the relevant actor-specific and transitional provisions. The European Commission published a recap on 1 June 2026, (details here).
Team-NB Publishes Version 2 of Its MDR Certification Process Consensus Document
On 4 June 2026, Team-NB published Version 2 of its position paper on the MDR certification process.
The document describes the MDR certification process, covering pre-application, application and post-application phases. It is presented by Team-NB as an association consensus paper and does not constitute an official regulatory position.
Source: Team-NB
Reference: Team-NB Position Paper — MDR Certification Process (Consensus Document), V2, 04 giugno 2026
FDA Announces Updated Guidance on Premarket Notification Exemptions for Certain Unclassified Devices
On 5 June 2026, the U.S. Food and Drug Administration announced the availability of updated guidance titled “Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements.”
The guidance describes the Agency’s intent to exempt from premarket notification 510(k) requirements certain unclassified medical devices that FDA intends to propose classifying into class I or class II.
According to the Federal Register notice, the updated guidance supersedes the June 2019 guidance of the same title and includes additional product codes.
Source: FDA – Center for Devices and Radiological Health (CDRH) / Federal Register
Reference: Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements, FDA guidance; Federal Register notice, 05 June 2026
ISO Publishes June 2026 Issue of ISO Update
ISO published the June 2026 issue of ISO Update, covering standards activity for the period from 1 May to 1 June 2026.
The issue highlights several standards projects relevant to medical device and IVD manufacturers.
Notable developments include ISO/DIS 23640, a proposed revision of the standard on stability evaluation of IVD reagents; ISO/DIS 10993-11.2, covering systemic toxicity testing within the biological evaluation of medical devices; and ISO/CD 8250, a new project addressing the characterization of residues relevant to biological evaluation.
The issue also lists ISO/DIS 11138-6 on biological indicators for vaporized hydrogen peroxide sterilization processes. These documents remain under development and have not yet been published as International Standards.
Source: ISO – International Organization for Standardization
Reference: ISO Update — June 2026; period covered: 01 May to 01 June 2026
FDA Issues Early Alert on Abiomed Catheter Introducer Kits
On 2 June 2026, the FDA published an Early Alert concerning Abiomed’s 14Fr Low Profile Introducer Kits.
The communication cites a higher-than-expected rate of complaints related to thrombus formation during prolonged use. According to the FDA, thrombus formation may disrupt blood flow near the access site and, if dislodged, may result in peripheral vessel obstruction with ischemia requiring prompt clinical assessment and intervention.
As of 15 May 2026, Abiomed had reported three serious injuries and no deaths associated with the issue.
Source: FDA – Center for Devices and Radiological Health (CDRH)
Reference: Early Alert: Catheter Introducer Kit Issue from Abiomed
FDA Issues Early Alert on GE HealthCare Infant Resuscitation Systems
On 5 June 2026, the FDA published an Early Alert regarding certain GE HealthCare infant resuscitation systems and warmers.
The issue concerns the air-oxygen blender knob shaft, which may loosen and affect the delivered oxygen concentration. The FDA stated that the device could deliver an oxygen concentration that does not match the selected setting, potentially resulting in hypoxia or hyperoxia.
As of 20 May 2026, GE HealthCare had reported no serious injuries or deaths associated with the issue.
Source: FDA – Center for Devices and Radiological Health (CDRH)
Reference: Early Alert: Infant Resuscitation System Issue from GE HealthCare
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