Our September 2025 MedTech news covers the latest regulatory updates from the EU, Switzerland, China, Canada, and Brazil. Find out about the EU Commission’s revised guidance on borderline and classification under MDR & IVDR, MedTech Europe’s call for a more risk-based approach to technical documentation review for IVDs, China’s alignment with ISO 10993, and Brazil’s new import rules for medical devices. For all this and more, read on…
MedTech news from the EU & Switzerland
EU Commission updates manual on borderline and classification under MDR & IVDR
The September 2025 update to the ‘Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746’ provides revised guidance to help stakeholders determine whether a product qualifies as a medical device or falls under other regulatory frameworks. Reflecting the latest decisions and interpretations from expert panels and regulatory bodies, the update aims to improve consistency in classification and ensure compliance with the evolving MDR and IVDR. Read more on this here.
MDCG updates guidance on master UDI-DI implementation for contact lenses
Updated at the end of August, MDCG 2024-14 Rev. 1 refines the implementation of the Master UDI-DI solution specifically for contact lenses. While the original guidance introduced the framework, Rev. 1 clarifies technical aspects and aligns the solution more closely with practical industry feedback and regulatory expectations. Read the updated guidance here.
MedTech Europe calls for risk-based approach to TD reviews for IVDs
MedTech Europe has urged the MDCG to adopt a more risk-based approach to sampling technical documentation for In Vitro Diagnostics (IVDs) under the IVDR. The current system disproportionately burdens lower-risk devices – especially for small companies – by requiring repeated reviews that divert resources from innovation and patient safety priorities.
MedTech Europe’s call for change encourages a focus on reviews of the highest-risk tests where patient safety is most critical, avoiding unnecessary duplicate assessments, and reducing costs and paperwork for smaller businesses. Read more on this here.
Team-NB outlines best practices for technical documentation submission
On 3 September, Team-NB shared a position paper outlining best practices for submitting technical documentation under Annex II and III of the IVDR. It aims to standardise submissions across notified bodies, improving clarity and consistency for IVD manufacturers. You can read the full paper here.
Swissmedic publishes swissdamed data dictionary
On 19 September, Swissmedic published the data dictionary for the UDI Devices module in swissdamed. You can access the swissdamed business rules, the data dictionary, and additional technical specifications for the upload of data to swissdamed in the technical documentation on the Swissmedic website.
MedTech news from China
China’s NMPA signals adoption of ISO 10993 for biological evaluation of medical devices
On 21 August, the NMPA released a draft of GB/T 16886.1-2025, adopting ISO/FDIS 10993-1:2025 for biological evaluation of medical devices. The update promotes a risk-based approach to safety – reducing unnecessary biological testing by using chemical characterisation, toxicological risk assessment, and comparative evidence. Read more on this here.
Shanghai issues new rules for transferring registered medical devices to local production
From 1 October this year, new rules issued by the Shanghai Municipal Medical Products Administration that allow medical devices with existing registration certificates to transfer into local production will become effective.
Marking a significant step in aligning Shanghai’s local regulatory framework with national policy, “Provisions on Transferring Medical Devices with Existing Registration Certificates into Shanghai Production” streamlines registration and licensing procedures, promotes fair treatment of domestic and imported products, and offers advisory services to support manufacturers. Find out more here.
MedTech news from Canada & Brazil
Health Canada shares medical device application type guidance
At the end of last month, Health Canada shared guidance to help manufacturers determine the appropriate application type for medical devices (such as device families, groups, systems, single devices, or test kits) – under Canadian regulations. It outlines criteria for combining components into one application and emphasises the importance of a clear rationale aligned with regulatory sections to ensure safety, quality, and effectiveness. Access the guidance here.
Brazil revises import rules with launch of DUIMP portal
At the end of last month, Brazil revised its import rules by launching the Duimp portal – streamlining licensing, ANVISA approvals, and customs procedures.
Aiming to reaffirm its commitment to promoting increasingly accessible, integrated foreign trade aligned with international best practices, on 29 August ANVISA approved for the first time a Single Import Declaration (Duimp) for products subject to health inspection, using the new risk analysis system of the Single Foreign Trade Portal. Find out more here.
That concludes our September 2025 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.