What has changed in the last month? Global regulatory developments

Europe

Swissmedic revises device registration fee information sheet, legacy device and payment rules added

Regulatory update: Swissmedic published Version 2.0 of its information sheet on the medical device registration fee in Swissdamed, valid from 27 October 2026.

Coverage: The revision adds a definition of a product for fee purposes, a rule that a legacy device newly registered under the MDR or IVDR counts as a new registration subject to the fee, payment rules, and a section on the Swissdamed invoicing dashboard.

Potential impact: Manufacturers, assemblers and their Swiss authorised representatives should check that the Actor Admin has set up the invoicing details in Swissdamed before initial billing starts in January 2027, and should budget for legacy devices re-registered under the MDR or IVDR being charged as new registrations. Read the full document here

Swissmedic revises Swissdamed business rules and user guides, importer linking added

Regulatory update: Swissmedic issued Version 5.0 of the Swissdamed Business Rules, valid from 2 September 2026, and updated the UDI Devices Module guide and the general User Guide for actors to cover importer linking, with both guides valid from 1 October 2026.

Coverage: The Business Rules revise rules UDI-1107 and UDI-1111, add rule UDI-1195 and remove UDI-1065. The UDI Devices Module guide adds chapters on checking whether a UDI-DI is already registered and on how importers link themselves to registered UDI-DIs at no cost, while the general guide introduces a “UDI Linker” profile for importers and explains how the inactivation of an actor affects users, devices and mandates.

Potential impact: Teams uploading UDI data should check their datasets against the revised rules to avoid rejected submissions, and manufacturers and authorised representatives outside Switzerland should expect their registrations to be linked to Swiss importers. Read the full documents here and here

Swissmedic revises FSCA guidance, anonymisation of private customers added

Regulatory update: Swissmedic published Version 3.3 of its guidance on field safety corrective actions (FSCAs) for economic operators, valid from 17 September 2026.

Coverage: The revision adds guidance on anonymising private individuals in the customer list that accompanies an FSCA report, for example by using their initials together with their place of residence or preferred language, and corrects a link to the website of the Liechtenstein National Administration.

Potential impact: Manufacturers and assemblers preparing an FSCA report should apply this approach when listing private customers. Read the full document here

Swissmedic clarifies assessment of modifications in combined studies

Regulatory update: Swissmedic revised its information sheet on combined studies, with Version 4.0 valid from 28 September 2026.

Coverage: The revision adds a remark to section 3, confirming that in a combined study the assessment of whether a substantial modification affects the device or IVD part should not be limited to the product itself, and should also take in elements such as consent forms, sites, eligibility criteria, follow-up assessments and endpoints.

Potential impact: Sponsors of combined studies should check each substantial modification against the whole study design, and contact Swissmedic where it is unclear whether a change affects the device or IVD part. Read the full document here

Swissmedic issues new version of vigilance contact person form for hospitals

Regulatory update: Swissmedic published Version 3.1 of its form for notifying a change of vigilance contact person, valid from 1 October 2026.

Coverage: Hospitals, including clinics, use the form under Art. 67 MepV and Art. 60 IvDV to register a new or additional vigilance contact person, to deregister the previous one, or to appoint a first contact person where they newly fall under the definition of a hospital.

Potential impact: Hospitals and clinics in Switzerland and Liechtenstein that change a vigilance contact person should ensure they submit the current version of the form. Read the full document here

MHRA updates good machine learning practice principles

Regulatory update: The UK’s MHRA updated its guidance on the ten guiding principles for good machine learning practice on 5 October 2026.

Coverage: The principles, identified jointly by the FDA, Health Canada and the MHRA, address the full lifecycle of AI and machine learning enabled devices, from multidisciplinary expertise and data quality to the performance of the human-AI team and monitoring after deployment. The page carries no change note, so the scope of the update is not stated.

Potential impact: Manufacturers of AI or ML enabled devices for the UK market should check the current text against their development processes, as the MHRA does not say what has changed. Read the full document here

Americas

FDA issues draft guidance on robotically-assisted surgical devices

Regulatory update: On 25 September 2026, the FDA issued draft guidance, “Robotically-Assisted Surgical Devices: Premarket Submissions”, with comments open until 24 November 2026 (docket FDA-2026-N-9505).

Coverage: The draft sets out recommended submission content for teleoperated, software-controlled systems, including non-clinical performance and reliability testing, software, cybersecurity, human factors, training, clinical data and labelling, and excludes pre-operative planning and stereotaxic systems, remotely teleoperated devices and autonomous robots.

Potential impact: As a draft, it is not for implementation; manufacturers of robotic surgical systems should review it against their planned submissions and consider commenting before the deadline. Read the full document here

FDA sets out labeling approach for prescription drug use-related software

Regulatory update: The FDA issued its guidance for industry, “Regulatory Considerations for Prescription Drug Use-Related Software”, in October 2026.

Coverage: The guidance applies to software disseminated by or on behalf of a drug sponsor, whether or not it is regulated as a device, and treats its end-user output as drug labeling. Device-connected functions are typically described briefly in the Prescribing Information, while standalone functions are included only where they are essential to safe and effective use or have shown a meaningful clinical improvement.

Potential impact: Developers and device manufacturers working with drug sponsors on companion apps should check how their software is likely to be classified for labeling, as this determines what the sponsor describes in the Prescribing Information. Read the full document here

FDA updates small entity guide on IND and BA/BE safety reporting

Regulatory update: The FDA issued Revision 1 of its Small Entity Compliance Guide on safety reporting for INDs and BA/BE studies in October 2026.

Coverage: The revision removes references to guidances that FDA has withdrawn and points instead to the December 2025 guidances on sponsor and investigator responsibilities. The changes are described as editorial, and the guide covers human drugs and biological products.

Potential impact: The guide is relevant to drug and biologic trials, and device manufacturers are not directly affected. Read the full document here

Asia-Pacific

TGA publishes overview of UDI requirements in Australia

Regulatory update: Australia’s Therapeutic Goods Administration (TGA) published its guidance page, “Overview of UDI in Australian healthcare”, describing the Unique Device Identification (UDI) system, the Australian UDI Database (AusUDID) and the phased compliance timeline.

Coverage: Mandatory compliance began on 1 July 2026 for high-risk devices and will apply progressively to other device classes until 30 June 2030. US and EU UDI-compliant labels are recognised, so manufacturers can use the same UDI across markets. Healthcare providers have no mandatory UDI requirements at present, and inclusion in the next edition of the National Safety and Quality Health Service Standards, due in 2028-29, is being considered.

Potential impact: Manufacturers and sponsors should check the compliance date for their device class. Existing US or EU UDIs can be used for the Australian market. Read the full document here

TGA updates guidance on clinical decision support software

Regulatory update: On 16 October 2026, the TGA updated its guidance, “Understanding clinical decision support system software regulation”, adding a note that it is under review to align with amendments taking effect on 1 November 2026.

Coverage: The update adds digital scribes to the software listed in the overview and removes the mention of AI from the exemption criteria section. The guidance sets out when CDSS software is excluded from TGA regulation, exempt from inclusion in the ARTG, or must be included, with exempt software still subject to notification, adverse event reporting and advertising requirements.

Potential impact: Manufacturers of CDSS software should reassess whether their product is excluded, exempt or must be included in the ARTG, and check the guidance again once the review is complete. Read the full document here

TGA updates guidance on Technical Master Files for blood products

Regulatory update: On 8 October 2026, the TGA updated and retitled its guidance on Technical Master Files for blood, blood components and haematopoietic progenitor cells, now “Preparing and maintaining a Technical Master File (TMF)”.

Coverage: The guidance covers when a TMF is required, what it should contain, submission and evaluation, fees, and the handling of amendments and annual updates. The page history says only that the guidance and its title were updated, so the individual changes are not stated.

Potential impact: The guidance is relevant to sponsors of blood products, and medical device manufacturers are not directly affected. Read the full document here

Associations

Team-NB releases updated version of Code of Conduct

Regulatory update: Team-NB, the European association of notified bodies, issued Version 5.3 of its Code of Conduct, dated 13 October 2026, adding a section on certificate falsification.

Coverage: Notified bodies that sign the code should have a quality management process for suspected falsified, altered or unauthorised use of certificates, covering the recording and investigation of the case and the preservation of evidence. Where necessary and proportionate, they may inform the competent authority, the certificate holder or the authorised representative.

Potential impact: Certificate holders and authorised representatives may be contacted about suspected misuse of a certificate, so keeping contact details current with the notified body helps ensure such a notice arrives. Read the full document here

TÜV SÜD white paper sets out early dialogue formats for MedTech start-ups

Regulatory update: In September 2026, TÜV SÜD published a white paper, “Leaving the Regulatory Ivory Tower”, on how start-ups can engage notified bodies well before certification.

Coverage: The paper describes four dialogue formats, addressing whether the regulatory and clinical roadmap is realistic, whether the intended purpose and risk class fit the business model, how regulatory maturity can be shown before CE marking, and what notified body support looks like after certification, particularly for software changes.

Potential impact: Start-ups can use these formats to test their regulatory assumptions at an early stage, and TÜV SÜD notes that investors may read early engagement as a sign of planning quality. Read the full document here