The week of 12–18 October 2026 brought several relevant regulatory updates in the medical device and in vitro diagnostic (IVD) sectors.
This edition covers EMA’s updated procedures for orphan medical devices, the European Commission’s decision publishing the reference to EN 18286 on AI quality management systems under the EU AI Act, and MHRA’s new strategy to 2030. The week also included an FDA Early Alert involving certain SAPIEN M3 delivery systems and the findings of Australia’s review of digital scribes.
In this issue
- EMA updates medical device procedures to include orphan device applications
- EU publishes EN 18286 reference under the AI Act
- MHRA publishes its strategy to 2030
- FDA issues Early Alert on certain Commander M delivery systems for SAPIEN M3
- TGA publishes digital scribe review findings and updates CDSS guidance
EMA Updates Medical Device Procedures to Include Orphan Device Applications
On 13 October 2026, the European Medicines Agency published an updated version of its Business process description for medical devices, effective from 12 October 2026.
The updated document incorporates the procedural management of orphan medical device applications.
It describes the process for obtaining expert-panel advice on orphan device status and subsequent clinical advice for successfully designated devices. This pathway is available to manufacturers and notified bodies and covers medical devices of any class, excluding in vitro diagnostic medical devices.
The document also describes clinical and performance evaluation consultation procedures, together with advice provided to manufacturers, the European Commission and the Medical Device Coordination Group.
The revision formally incorporates orphan device applications into EMA’s documented medical device procedures without introducing new requirements under the MDR.
Source: EMA
Reference: Business process description — Medical Devices
EU publishes EN 18286 reference under the AI Act
On 14 October 2026, Commission Implementing Decision (EU) 2026/2274, adopted on 12 October 2026, was published in the Official Journal of the European Union. The Decision concerns harmonised standards for high-risk AI systems in support of Regulation (EU) 2024/1689 (AI Act).
The Decision publishes the reference to EN 18286:2026 — Artificial intelligence — Quality management system for EU AI Act regulatory purposes, addressing quality management systems for providers of AI systems, including post-market monitoring processes.
Compliance with the harmonised standard provides a presumption of conformity with the AI Act requirements covered by the standard. However, this presumption does not extend to the entire AI Act or, by virtue of this citation, to the requirements of the MDR or IVDR.
EN 18286:2026 is also relevant to manufacturers of AI-enabled medical devices and IVDs that qualify as high-risk AI systems under the AI Act.
The AI Act allows its quality management requirements to be integrated into existing quality management systems established under applicable sectoral legislation.
The publication therefore introduces an important harmonised-standard reference for AI quality management, while maintaining the distinction between conformity with the AI Act and compliance with medical device legislation.
Source: European Commission
Reference: Commission Implementing Decision (EU) 2026/2274; AI Act — Articles 6 and 17 and Annex I
MHRA Publishes Its Strategy to 2030
On 14 October 2026, the Medicines and Healthcare products Regulatory Agency published its strategy to 2030, setting out priorities for patient involvement, regulatory services, safety monitoring and innovation.
For medical devices, the strategy includes the development of a modernised regulatory framework for MedTech and artificial intelligence.
MHRA also intends to establish clearer regulatory pathways and promote earlier engagement with developers, alongside greater use of data, analytics and AI to identify safety risks throughout the product lifecycle.
Another priority is strengthening international partnerships to reduce duplication and support access to innovative medical technologies.
The strategy outlines the Agency’s direction for the coming years. It does not itself introduce new regulatory requirements or replace the detailed measures needed to implement the announced commitments.
Source: MHRA
Reference: MHRA Strategy 2030 — Executive summary
FDA Issues Early Alert on Certain Commander M Delivery Systems for SAPIEN M3
On 15 October 2026, FDA published an Early Alert concerning certain Commander M delivery systems used with the SAPIEN M3 Transcatheter Mitral Valve Replacement System.
The alert follows a manufacturer communication issued by Edwards Lifesciences on 5 October 2026.
The affected products belong to four specified lots: 67718561, 67804014, 67887043 and 67887044.
Edwards Lifesciences reported three instances of balloons bursting during inflation. Potential consequences include embolism and difficulties retrieving the device, which may require additional intervention.
As of 5 October 2026, the manufacturer had reported one death and one serious injury associated with the issue. These reports do not, by themselves, establish a causal relationship with the reported device problem.
FDA advises against using the affected products and states that delivery systems with other lot numbers are not impacted by the recall.
The Early Alert identifies a safety concern involving specific lots of a delivery system used in transcatheter mitral valve replacement.
Source: FDA
Reference: Early Alert: Transcatheter Mitral Valve Delivery System Issue from Edwards Lifesciences
TGA Publishes Digital Scribe Review Findings and Updates CDSS Guidance
On 16 October 2026, Australia’s Therapeutic Goods Administration published the findings of its review of digital scribes supplied in Australia.
The Agency identified approximately 100 suppliers, received responses from 40 and focused its review on 12 products.
None of the suppliers of those 12 products identified their products as medical devices. However, TGA found that eight products included functions likely to meet the definition of a medical device, while two required further information and two appeared unlikely to qualify based on the information available.
The findings highlight how some digital scribes have evolved beyond transcription and clinical documentation to include functions that generate clinical conclusions or recommendations.
TGA clarified that the review did not include product testing or a detailed assessment of safety, performance or regulatory compliance.
Alongside the report, TGA updated its guidance on clinical decision support system (CDSS) software to include digital scribes.
The Agency also noted that the guidance is under review to align with regulatory amendments taking effect on 1 November 2026.
The findings highlight the importance of intended purpose and software functionality in determining regulatory status. Describing a digital scribe as an administrative or documentation tool does not, by itself, establish that it falls outside medical device regulation.
Read the dedicated insight: Digital scribes and medical devices: what the TGA review found
Source: Therapeutic Goods Administration
Reference: Digital scribe review outcomes; Understanding clinical decision support system software regulation
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