Our summer MedTech roundup gathers the latest in industry news from July and August from regulators around the world. Find out the latest about swissdamed, digitalised IFU, and guidances on clinical investigations, adverse event reporting in DMHTs, and animal studies for dental bone grafting material devices. Plans for accelerating patient access to innovative medical devices also feature, as well as classification updates and news of continued cross-border regulatory collaboration. Read on for more…
MedTech news from Switzerland & the EU
Latest swissdamed module goes live
The new UDI Devices module in swissdamed is now live. It can be used to register medical devices, in vitro diagnostic medical devices, and systems and procedure packs – and whilst module use is currently voluntary, registration will be mandatory from mid next year.
Swissmedic shares information on systems and procedure packs
Swissmedic has shared an information sheet outlining the obligations for the assembly and labelling of systems and procedure packs, as well as the associated obligations of economic operators in Switzerland and Liechtenstein, as per MedDO and IvDO.
Access the information sheet here.
Medical device eIFU now available in EU and Switzerland
Healthcare professionals will now be able to receive instructions for use of medical devices in electronic format, rather than solely on paper, following an EU Commission regulation.
The regulation applies to all medical devices used by healthcare professionals within the EU. The adoption of electronic instructions for use is part of the Commission’s broader initiative to modernise healthcare, support environmental sustainability, and alleviate financial and administrative pressures on device manufacturers.
Read more on this here, and for more about how Swissmedic is adopting these new EU requirements with immediate effect, see here.
Team NB shares perspective on future governance in EU medical device sector
At the end of July, Team NB shared a paper presenting a notified bodies’ perspective on future governance in the EU medical device sector. Proposing centralised support, improved coordination, and sustainable funding, the paper draws on recent EU policy developments and feedback from notified bodies.
EU Commission publishes study on deployment of AI in healthcare
The EU Commission has shared a study that identifies a range of challenges to AI deployment in healthcare, spanning technological and data-related issues, legal and regulatory complexities, organisational and business challenges, and social and cultural barriers.
The study also highlights successful strategies employed by hospitals globally to overcome these common obstacles, and presents considerations for future action to enable the sustainable integration of AI into healthcare systems.
MedTech news from the UK
MHRA updates guidance on clinical investigation applications
A clinical investigation may be required as part of the process to obtain a UKCA, CE or CE UKNI marking for a medical device – and the UK’s MHRA must be informed at least 60 days prior to starting the investigation. At the end of August, the MHRA shared a flow chart and accompanying guidance to assist with determining the need for a clinical investigation application for studies in Great Britain and Northern Ireland.
Read the guidance for Great Britain and Northern Ireland here.
MHRA shares guidance on adverse event reporting in DMHTs
In August, the MHRA published advice for manufacturers of digital mental health technologies (DMHTs) that qualify as software as a medical device (SaMD) on understanding new post-market surveillance rules.
The updated regulatory guidance marks a significant step forward in ensuring the safety and effectiveness of DMHTs. By providing clear examples of serious incidents and involving a diverse group of stakeholders in the development process, the guidance helps manufacturers and stakeholders navigate the regulatory landscape and ultimately protect users.
You can read more on this here.
MHRA to accelerate patient access to innovative medical devices
The MHRA has outlined its intent to speed up patient access to innovative medical devices. The Statement of Policy Intent sets out initial thinking on a new Early Access service to help patients benefit sooner from innovative medical devices that address unmet clinical needs.
Designed to support innovators, including small and medium-sized enterprises, the new Early Access service will aim to provide time-limited, conditional access to promising technologies ahead of full regulatory approval, where there is clear clinical need and supporting evidence of patient benefit.
NIAIC function now closed
The Northern Ireland Adverse Incident Centre (NIAIC) incident and reporting function closed from the 1 August this year. Healthcare professionals in Northern Ireland will now need to report adverse incidents involving medical devices to the Yellow Card scheme in accordance with their organisation’s medical device policies and procedures.
MHRA releases standardised format for PSUR
At the end of June, the MHRA published updated documentation to provide information and recommendations for manufacturers on the preparation and presentation of a periodic safety update report (PSUR).
The document guides manufacturers on what data to include within a PSUR, stating that it’s not mandatory to include sections which do not apply, and data may be displayed in an alternative form if appropriate.
MedTech news from the US & Canada
FDA releases final guidance on animal studies for dental bone grafting material devices 510(k) submissions
In August, the FDA published final guidance regarding animal studies to support premarket notification (510(k)) submissions for dental bone grafting material devices. The recommendations aim to assist manufacturers in complying with some special controls for these devices.
The guidance also provides recommendations that support the 3Rs of replacing, reducing and/or refining animal use, and encourages manufacturers to consult the FDA if they wish to use a non-animal testing method they believe is suitable.
FDA issues final guidance on PCCPs for AI-enabled devices
The FDA has issued final guidance that provides recommendations for predetermined change control plans (PCCPs) tailored to artificial intelligence (AI)-enabled devices.
Applicable to AI-enabled devices (including the device constituent part of device-led combination products) reviewed through the 510(k), De Novo, and PMA pathways, the guidance intends to support iterative improvement through modifications to AI-enabled devices while continuing to provide a reasonable assurance of device safety and effectiveness.
The document recommends that a PCCP describes the planned device modifications, the associated methodology to develop, validate, and implement those modifications, and an assessment of their impact.
FDA publishes final guidance on premarket submissions for devices with cybersecurity risk
Published in June, “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” provides the FDA’s recommendations to industry regarding cybersecurity device design, labelling, and the recommended documentation to include in premarket submissions for devices with cybersecurity risk.
Superseding the final guidance issued on 27 September 2023, this latest document also addresses the FDA’s recommendations regarding section 524B of the FD&C Act for cyber devices.
Health Canada to launch second eSTAR pilot
Following positive feedback from participants involved in an initial pilot that demonstrated proof of concept, Health Canada is launching a second eSTAR pilot that expands the scope of submission types.
Under this second pilot, medical device manufacturers can submit an eSTAR submission for either a new or significant change amendment application for a Class III or IV device, including both in vitro diagnostic devices (IVDDs) and non-in vitro diagnostic devices (non-IVDDs).
MedTech news from Asia
China’s NMPA proposes updates to medical device classification catalogue
On 7 August, China’s NMPA issued the “Notice on Soliciting Opinions on Adjustments of the Medical Device Classification Catalogue”.
Demonstrating the NMPA’s commitment to improve regulatory clarity and align the risk-proportionate oversight with global regulatory best practices, the proposal includes downgraded classifications, clarifications for market access, and regulatory adjustments to specialised fields.
You can read more about this here, including how to submit feedback on the proposal by 10 September.
NMPA shares classification results
In July, the NMPA shared insights from the 2024–2025 classification results, related to opportunities for imported combination products entering China. “Drug-Device Combination Products Classification Results (June 2024 to May 2025)” identifies seven drug-led combination products and 46 device-led combination products.
Japan’s PMDA and the Republic of Korea’s MFDS celebrate continued regulatory cooperation
The Ministry of Health, Labour and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA), Japan, and the Ministry of Food and Drug Safety (MFDS), the Republic of Korea, have confirmed their continued commitment for regulatory cooperation in the medical products field.
In a joint statement released in July, the two regulators celebrated ten years of embedding harmonization in their regulatory requirements – aligning international regulatory harmonization frameworks for pharmaceuticals and medical devices.
That concludes our Summer 2025 MedTech news roundup. We’ll be back at the end of September with more medical device news and updates.
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