Is it Too Bold to Refer to this as the Quarter of Data Accessibility?: Second Quarter 2025 Developments

By Evangeline Loh

We at Emergo by UL continue to monitor and share regulatory updates and news after the first quarter. We’ve divided the developments this quarter into three topics: regulatory data, quality management system (QMS) and medical device software (MDSW).

If there is one theme, it is the influence of the International Medical Device Regulators Forum (IMDRF), Medical Device Single Audit Program (MDSAP) and regulatory reliance.

Regulatory databases and market data transparency

Progress abounds in data and databases. We reported on functionality in both the medical device databases from the U.S. Food and Drug  Administration (FDA) 510(k) database, as well as the European database for medical devices, EUDAMED. The FDA Office of Communication, Information Disclosure, Training and Education (OCITE) added six new subcategories to the 510(k) database. Three of the six subcategories were also added to the search functionality in the premarket approval  (PMA) database.  In the EUDAMED device module you can search on device type, select from more than 20 options, plus other device attributes. Expect an update about EUDAMED and certain modules becoming compulsory.

In addition, there has been progress reported with the Unique Device Identifier Systems (UDI). UDI legislation was introduced by Australia (March 24) with accompanying TGA guidance. The first deadline for UDI carrier on the label, Class III and Class IIb devices, and including the UDI record in the Australian Therapeutic Goods Administration (TGA) UDI database, AusUDID, is July 1, 2026. In Brazil, the first deadline for UDI labeling applies to Class IV devices on July 10, 2025. A Normative Instruction will be released soon for Brazil’s medical device market regulator, ANVISA’s UDI database, SIUD, with associated deadlines.

This seems to improve the data available about the devices, device traceability and publicly accessible information.

Quality management systems, including PMS and Vigilance

As much as we prefer to keep post-market surveillance (PMS) as a separate topic, this quarter, it is presented with quality management systems (QMS).

In South Korea, MFDS Notice No. 2025-22 consolidated the Korea Good Manufacturing Practice (KGMP) quality system legislation, and specified that for Class 3 medical devices KGMP, an audit by the Third Party Auditor (TPA) suffices. In Mexico, NOM-241-SSA1-2025 on Good Manufacturing Practices was finalized (April 4). Of note related to UDI, all references to UDI have been officially removed. The South Africa medical device regulator, SAHPRA, issued (April 9) phased-in requirements to ISO 13485 with the first deadline of June 1 and joined MDSAP as an affiliate member. Last, there has been news of the EU seriously contemplating MDSAP.  

The EU Manufacturer Incident Report Form (MIR) version 7.3.1  was released May 5 for reporting incidents and now requires IMDRF Adverse Event Codes. Switzerland’s medical device regulator, SwissMedic subsequently adopted the EU MIR with corresponding guidance. And, the UK medical device regulator MHRA followed in quick succession with guidance outlining implementation of MIR and FSCA reports in the vigilance reporting database, MORE. In addition, to align with the PMS regulations coming into force (June 16), the MHRA published resources for the new UK MIR and FSCA Report Schema.  

Medical device software

Lastly, retaining a topic from last quarter, we note there has been continuous legislation and guidance from regulators on software. The EU guidance on qualification and classification of software was revised, MDCG 2019-11, Revision 1. The changes may seem small, though potentially significant. The guide adds AI to the scope, discusses requirements for modular MDSW, adds Rule 11 examples of MDSW, which are now possibly higher risk to Class IIa. In addition, there are now more Class I MDSW examples.

To the EU AI Act, guidance on AI literacy and MDCG 2025-6 on KGMP quality system regulations. frequently asked questions (FAQs) on the medical device and IVD regulations and the AI Act were released. Not to be forgotten is the guidance on MDSW apps on online platforms (MDCG 2025-4). The UK MHRA issued guidance on AI airlock and the U.S. FDA issued guidance on cybersecurity.

Since we mentioned eIFU last quarter,  Implementing Regulation (EU) 2025/1234 was published, legally formalizing electronic instructions for use (eIFUs).

Concluding remarks

The medical device regulator in Mexico, COFEPRIS, announced new options for regulatory reliance (equivalence), referred to as reference regulatory authorities (RRA). The June 11, equivalence agreement expands the current RRA to include the U.S. FDA, Health Canada and Japan PMDA. Only time will tell what will be required for the other RRAs.

Regulators continue to embrace the activities of the IMDRF and MDSAP. Global developments are noted while regulators continue to advance their objective of protecting the patients and citizens of their countries.