Our MedTech news for September 2026 covers AI regulation across several jurisdictions, IVD classification and vigilance guidance, and medical device regulatory reform in the UK.

In Europe, the MDCG revised its IVD classification guidance, the Commission updated its COMBINE pilot sponsor guide, Team-NB launched the DIGICAP project, and Swissmedic published new good practice guidance on IVD materiovigilance. Whilst in the UK, the Health Bill advanced plans for a medical device licensing regime, and a national commission set out recommendations for regulating AI in healthcare.

In the US, the FDA issued a draft PMA electronic submission template and a proposed list of accessories for Class I classification, alongside a PFAS FAQ update and an upcoming rare disease patient voice meeting.

And in Asia Pacific, China’s NMPA released a series of AI, clinical evaluation, registration, and GMP inspection guidance, Japan’s PMDA published generative AI review criteria, and Australia’s TGA amended its CDSS exemption, classification rules, and Essential Principles evidence guidance.

Read on for more…

MedTech news from the EU & Switzerland

MDCG revises IVD classification guidance on Rule 7

On 9 September, the Medical Device Coordination Group (MDCG) published revision 5 of MDCG 2020-16, its guidance on classification rules for in vitro diagnostic medical devices under Regulation (EU) 2017/746. The update revises Rule 7 – clarifying the rationale behind the rule and revising the accompanying examples. Read the guidance here.

EU Commission publishes updated sponsor guide for COMBINE Project 1 pilot

On 3 September, the EU Commission published version 02.01 of the Sponsor Guide for the COMBINE Project 1 pilot. The pilot synchronises the authorisation and ethics committee reviews of combined studies into a single process, meaning submission, validation, and assessment happen simultaneously. It also aligns the timing of the required authorisations and decisions for multinational combined studies. Read the sponsor guide here.

Team-NB launches DIGICAP project

At the start of this month, Team-NB announced the official launch of DIGICAP (DIGItalisation of the Conformity Assessment Process). The project will run for three years under the EU’s Horizon Europe programme. Find out more here.

Swissmedic publishes good practice guideline for IVD materiovigilance

On 10 September, Swissmedic published the Swiss Good Practice for Materiovigilance of In Vitro Diagnostics (GPMV-IVD). The guideline combines binding legal requirements with practical recommendations, and marks each clearly so readers can see what is mandatory and what is supporting guidance. Its structure and worked examples are designed so it can serve both as a reference document and as an orientation guide to IVD vigilance obligations in Switzerland. Read the guideline here.

MedTech news from the UK

National Commission sets out recommendations for regulating AI in healthcare

This month, the National Commission into the Regulation of AI in Healthcare published its recommendations for a future regulatory framework. The Commission was established to advise the Government on how AI in healthcare should be regulated, and its latest report addresses both the opportunities and the risks. Access the full report here.

Health Bill advances plans for a medical device licensing regime

On 1 September, the MHRA announced that amendments supporting its regulatory reform programme had been tabled in the Government’s Health Bill. The amendments cover information sharing, regulatory reform, and the future development of a medical device licensing regime. On 9 September, the Government followed with an impact assessment of the proposed licensing regime, setting out its objectives, rationale, costs and benefits. Read the MHRA announcement here and find the impact assessment here.

MedTech news from the US

FDA issues draft guidance on electronic submission template for PMAs

The FDA has published draft guidance on an electronic submission template for Premarket Approval (PMA) applications and certain PMA supplements submitted to CDRH and CBER. The draft introduces the publicly available resources developed to support electronic PMA submissions and is part of the FDA’s commitment to develop guided submission templates that improve consistency and review efficiency.

Once finalised, the guidance will set further standards for electronic submission, a timetable for establishing them, and criteria for waivers and exemptions. Read the draft guidance here.

CDRH proposes list of accessories for distinct Class I classification

On 26 August, the FDA’s Center for Devices and Radiological Health (CDRH) issued a proposed list of accessories suitable for distinct classification in Class I and requested public input. Eligible accessories are those that already hold marketing authorisation and for which general controls are sufficient to provide reasonable assurance of safety and effectiveness. Read more on this here.

FDA adds FAQs to its PFAS in medical devices page

On 1 September, the FDA updated its “PFAS in Medical Devices: What You Need to Know” page with a new frequently asked questions section. The FAQs address common questions about the use of per- and polyfluoroalkyl substances (PFAS) in medical devices. See more on this here.

FDA to hold meeting on the patient voice in rare disease product development

The FDA and the Reagan-Udall Foundation will convene a hybrid meeting on the patient voice in rare disease medical product development, covering drugs, biologics and devices. Set for 16 October, the meeting will explore where patient input is sought across the development timeline, what impact it has, and further opportunities for patients to engage. Insights from the discussions will inform recommendations for product developers and regulators on patient-centred approaches. Find out more and register for the event here.

MedTech news from Asia Pacific

NMPA releases AI, clinical evaluation, registration, and GMP inspection guidance

In mid-September, China’s National Medical Products Administration (NMPA) released a series of guidance documents, four of them as drafts for public comment:

• Guidelines for the Registration of Artificial Intelligence Medical Devices (Revised 2026), draft for comment (11 September), covering lifecycle processes and registration dossiers for AI-based devices
• Guidelines for the Registration of Active Medical Devices (Revised 2026), draft for comment (11 September), covering service-life studies and registration dossiers for active devices
• Guidelines for Clinical Evaluation and Registration Review of AI-Assisted Decision-Making Medical Devices for Multiple Diseases, draft for comment (16 September)
• Guidelines for Clinical Evaluation and Registration Review of Implantable Deep Brain Stimulation Systems, draft for comment (16 September)
• Guidelines for Inspection of Medical Device Manufacturing Quality Management Standards (16 September), final guidance replacing the previous on-site inspection guidelines (No. 218) ahead of the revised Code of Quality Management for Medical Device Production taking effect on 1 November 2026

PMDA publishes review criteria for generative AI medical devices

On 18 September, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) published draft review criteria for AI-powered programmed medical devices that incorporate generative AI. The criteria focus on generative AI systems that produce diverse responses to natural language or voice queries without being constrained to specific tasks, particularly where they are implemented as large language models (LLMs) or vision language models (VLMs). The scope covers medical devices that rely on such generative AI to achieve their functionality. Read the review criteria here.

TGA amends the clinical decision support system exemption

On 8 September, Australia’s Therapeutic Goods Administration (TGA) announced amendments to the clinical decision support system (CDSS) exemption to clarify when it applies. The amendments will take effect from 1 November this year. They do not change the scope of the exemption or introduce new regulatory requirements. CDSSs that meet the definition of a medical device must generally be included in the Australian Register of Therapeutic Goods (ARTG) unless exempt or excluded, and the exemption continues to cover certain lower-risk CDSSs that meet its criteria. Read more on this here.

TGA introduces new classification rule for certain combination products

Also on 8 September, the TGA announced a new classification rule for non-invasive medical devices used to maintain the patency of, or flush the lumen of, another medical device. The rule was introduced through changes to Part 2 of Schedule 2 of the Therapeutic Goods (Medical Devices) Regulations 2002. Read more on this here.

TGA updates guidance on demonstrating compliance with the Essential Principles

This month, the TGA updated its guidance on demonstrating evidence to comply with the Essential Principles. The revisions cover three sections: generating suitable evidence, the types of evidence manufacturers could hold, and the Essential Principles checklist. Read the guidance here.

That concludes our September 2026 MedTech news roundup. We’ll be back in October with more medical device news and updates.

Found this useful? To receive our MedTech news direct to your inbox, you can subscribe to our monthly Knowledge update.