The week of 5–11 October 2026 brought several relevant regulatory updates in the medical device and in vitro diagnostic (IVD) sectors.
This edition covers the first medical devices selected for EU-level Joint Clinical Assessment, the UK Government’s response on AI regulation in healthcare, and FDA’s expanded 510(k) exemptions for certain toxicology test systems.
The week also included newly published IMDRF documents and three Team-NB publications on IVDR certification, expert panels and regulatory reform.
In this issue
- European Commission selects first medical devices for Joint Clinical Assessment
- UK Government backs AI Commission recommendations and MHRA opens AI Airlock Phase 3
- FDA expands 510(k) exemptions for certain clinical toxicology test systems
- IMDRF publishes Singapore meeting outcome statement and UDI workshop summary
- Team-NB publishes documents on IVDR certification, expert panels and regulatory reform
European Commission Selects First Medical Devices for Joint Clinical Assessment
On 6 October 2026, the European Commission announced the first selection of medical devices for Joint Clinical Assessment under the EU Health Technology Assessment Regulation.
The underlying implementing decision was adopted on 2 October 2026.
Selected devices are the SAPIEN M3 Transcatheter Mitral Valve Replacement System, manufactured by Edwards Lifesciences, and the HighLife Trans-Septal Mitral Valve Replacement System, manufactured by HighLife SAS.
The selection follows the recommendation of the HTA Coordination Group adopted on 22 June 2026.
This assessments will produce joint reports intended to support national decision-making procedures. The assessment results have not yet been published.
This announcement marks the start of Joint Clinical Assessment work on medical devices under the EU Health Technology Assessment Regulation.
Source: European Commission
Reference: HTA Regulation — Commission selects first medical devices for joint clinical assessment
UK Government Backs AI Commission Recommendations and MHRA Opens AI Airlock Phase 3
On 6 October 2026, the UK Government accepted all 44 recommendations of the National Commission into the Regulation of AI in Healthcare, whose report was published on 10 September 2026.
Alongside the response, MHRA opened applications for AI Airlock Phase 3, focusing on post-market surveillance and lifecycle regulation of AI-enabled medical devices.
The announced commitments include draft guidance on managing changes to AI-enabled devices by December 2026 and a consultation on qualification and classification in 2027.
A full implementation roadmap is expected by spring 2027.
These are announced policy and guidance-development commitments, rather than newly adopted regulatory requirements.
The response signals how the UK intends to move towards lifecycle-based regulation of AI-enabled medical devices.
Read the dedicated insight: UK accepts 44 healthcare AI recommendations as MHRA opens AI Airlock Phase 3
Source: UK Government / MHRA
Reference: Government backs recommendations of NHS doctors-led AI Commission
FDA Expands 510(k) Exemptions for Certain Clinical Toxicology Test Systems
On 6 October 2026, FDA published a final order expanding 510(k) exemptions for certain Class II clinical toxicology test systems to include devices intended for Federal drug testing programmes.
The order took effect on the same day. The change removes the previous exclusion of Federal drug testing programmes from these exemptions.
These exemptions remain limited to specified test systems intended solely for employment and insurance testing, with corresponding labelling and subject to the general limitations in 21 CFR 862.9.
The order does not establish a general exemption for all clinical toxicology tests.
Read the dedicated insight: FDA expands 510(k) exemptions for certain toxicology test systems
Source: FDA
Reference: Medical Devices; Exemptions From Premarket Notification: Class II Devices; Certain Clinical Toxicology Test Systems
IMDRF Publishes Singapore Meeting Outcome Statement and UDI Workshop Summary
On 7 October 2026, IMDRF published the outcome statement from its 30th session, held in Singapore on 14–18 September 2026.
The Management Committee agreed to release a revised draft of its Principles of Labelling for Medical Devices for public consultation.
It also approved new work on Remedial Action Codes for describing industry corrective actions.
On 8 October 2026, IMDRF also published the summary of its 9 June UDI workshop.
The workshop summary identifies differences in UDI-DI assignment triggers, data definitions and database structures as priorities for further alignment.
The publications report decisions and proposed harmonisation activities. They do not introduce new binding requirements.
The documents point to ongoing international convergence work on labelling, corrective-action terminology and UDI implementation.
Source: IMDRF
Reference: IMDRF 30th MC Meeting Singapore September 2026 — Outcome Statement; Global IMDRF UDI workshop — June 2026
Team-NB Publishes Documents on IVDR Certification, Expert Panels and Regulatory Reform
Between 6 and 8 October 2026, Team-NB published three documents addressing IVDR certification and the evolving EU medical device regulatory framework.
On 6 October, Team-NB published Version 2 of its consensus document on the IVDR certification process. The document describes the pre-application, application and post-application stages, including conformity assessment, certification and surveillance, for both legacy and new IVDs.
On 7 October, Team-NB published a position paper on participation in expert panels. The paper proposes participation by notified body experts in an individual capacity, with safeguards for independence, confidentiality and conflicts of interest.
On 8 October, Team-NB published a statement on revising the medical device regulatory framework. The statement sets out the association’s concerns and proposals on risk-adapted surveillance, notified body access to EUDAMED, regulatory definitions and fee measures.
These publications express the position of the European association of medical device notified bodies and do not constitute official EU guidance or new regulatory requirements.
Source: Team-NB
Reference: IVDR Certification Process — Version 2; Participation in Expert Panels; Revising the Medical Device Regulatory Framework
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