Our October MedTech news roundup covers new harmonised standards from the EU Commission, the latest on swissdamed, and guidances from the FDA on computer software assurance, enforcement policies for IVD tests, and E20 adaptive designs for clinical trials. Updates from Japan’s PMDA and China’s NMPA also feature. Read on for more…
EU Commission publishes new harmonised standards
On 17 October the EU Commission published new harmonised standards under the medical device regulations. Commission Implementing Decision (EU) 2025/2078 amends Implementing Decision (EU) 2021/1182 regarding harmonised standards for surgical clothing and drapes, medical face masks and sterilizers for medical purposes. Find out more about the standards here.
Discard functionality now available in UDI devices swissdamed module
As of this month, the discard functionality has become available in the UDI Devices module of swissdamed. This now means that registered UDI-DIs can be discarded if they contain incorrect data which cannot be corrected via an update due to the business rules.
The discard functionality is only allowed to be used for the correction of incorrectly submitted data, and not for changes to devices. Read more on this here.
FDA issues guidance on computer software assurance for production & quality system software
At the end of September, the FDA issued guidance to provide recommendations on computer software assurance for computers and automated data processing systems used as part of medical device production or the quality system.
Aiming to help manufacturers produce high quality medical devices while complying with the Quality System regulation, 21 CFR Part 820, the guidance describes a risk-based approach to establish confidence in the automation used for production or quality systems and identify where additional rigor may be appropriate. Various methods and testing activities that may be applied to establish computer software assurance are also included. You can access the guidance here.
FDA publishes guidance on enforcement policies for IVD tests during section 564 declared emergencies
Last month, the FDA shared final guidance to describe their assessment factors for deciding on the issuing of enforcement policies regarding test manufacturers’ offering of certain unapproved in vitro diagnostic tests during a future relevant declared emergency under section 564 of the FD&C Act. Read the final guidance here.
FDA shares draft guidance on E20 adaptive designs for clinical trials
The FDA has shared draft guidance to provide a transparent and harmonised set of recommendations for clinical trials with an adaptive design. The draft guidance emphasises the critical principles for the planning, conduct, analysis, and interpretation of clinical trials with an adaptive design that aim to confirm the efficacy and support the benefit-risk assessment of a treatment. Available for comment until 1 December this year, you can access the draft guidance here.
Japan’s PMDA releases action plan for AI use in operations
Japan’s PMDA has released an action plan to proactively integrate artificial intelligence (AI) technologies into its operations. The initiative aims to enhance the agency’s overall efficiency and effectiveness, serving as a strategic guideline for future AI adoption. Find out more here.
China’s NMPA releases first brain-computer interface medical device terminology standard
The NMPA has released the industry standard YY/T 1987-2025, titled “Brain-Computer Interface Medical Equipment – Terminology”. Representing China’s first official standard dedicated to brain-computer interface (BCI) medical devices, it provides a structured framework that intends to guide research, development, regulation, and application of BCI technologies in healthcare. See more on this here.
That concludes our October 2025 MedTech news roundup. We’ll be back in November with more medical device news and updates.
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