New Australian UDI regulations are now in effect, the impact of the revised EU REP symbol on medical device labeling in the European Union, Mexico's COFEPRIS has announced modifications to GMP requirements, and more in this week's global medical device regulatory updates.
As of 25 March 2025, the Australian Unique Device Identification (UDI) regulatory framework is officially in force following the approval of final amendments to the Medical Device Regulations.
After a delay in implementation, the Therapeutic Goods Administration (TGA) has enabled voluntary compliance for sponsors and manufacturers. Mandatory compliance will follow a staggered timeline based on the risk classification of the medical device:
Sponsors can now begin submitting UDI data to the Australian UDI Database (AusUDID):
AusUDID Search & Submission Portal
To support industry in preparing for these new requirements, the TGA has published a range of guidance materials and tools:
Key Resources:
This marks a significant step in aligning Australia's regulatory approach with global UDI systems, improving device traceability, patient safety, and supply chain oversight.
For the official announcement and further details, see:
https://www.legislation.gov.au/F2025L00414/latest/text
Learn more about TGA Australia Medical Device Registration.
In February 2025, MedTech Europe, AESGP, the MedTech & Pharma Platform, and COCIR released a joint position paper urging for urgent clarification on pre-submission clinical strategy discussions between manufacturers and Notified Bodies. Despite encouragement from the European Commission for structured dialogues, the industry faces uncertainty regarding the process and deliverables. The paper stresses the importance of early feedback on clinical strategies to avoid delayed discussions in the review process. MedTech Europe proposes a clearer framework similar to the Q-Submission process in the US FDA but emphasizes the need for clarification of the roles and expectations of both manufacturers and Notified Bodies. For more information, visit MedTech Europe’s Call for Clarity on Clinical Strategy Discussions.
In March 2025, ISO 15223-1:2021/Amd 1:2025 introduces an important update to the symbol used for the European Authorized Representative (EC REP), now replacing "EC REP" with "EU REP" to align with current EU terminology and harmonize standards across the European market. This change addresses concerns about confusion with other sectors and country codes, particularly Ecuador's "EC" code. Although the change is not yet officially harmonized with the MDR/IVDR, medical device manufacturers are advised to update their labeling to ensure consistency with the revised symbol. The ISO update is part of a broader harmonization effort, with no official transition timelines provided as of yet. For more details, visit ISO 15223-1:2021/Amd 1:2025.
In March 2025, the EU Commission's Committee C49800 announced a new initiative to update and create common specifications for high-risk In Vitro Diagnostic (IVD) medical devices, particularly for class D devices. This includes tests for hepatitis E virus, Toxoplasma gondii, Plasmodium (malaria), and four types of arboviruses—dengue, Chikungunya, West Nile, and Zika viruses. The new Commission adoptions are scheduled for the second quarter of 2025. The initiative aims to enhance the safety and performance standards for these critical diagnostic devices. For further details, visit EU Commission Initiative on IVD Common Specifications.
In February 2025, the European Commission launched a second call to Member States for applications to designate EU Reference Laboratories (EURLs) for high-risk In Vitro Diagnostic (IVD) devices, in line with Regulation (EU) 2017/746. This follows the initial wave of EURL designations completed in 2023, with the laboratories commencing their role in October 2024. The call is divided into two phases:
These designations are essential to support the conformity assessment of high-risk IVD devices. EURLs play a critical role in ensuring the safety and effectiveness of these devices, which are crucial for public health. The new call aims to expand the capacity and expertise in the assessment of the most complex diagnostic technologies.
For more detailed information on the application process, visit the EU Reference Laboratories EURLs page.
Learn more about EU Medical Device Registration.
The Federal Commission for the Protection against Health Risks (COFEPRIS) has announced key modifications to NOM-241-SSA1-2025, the Mexican Official Standard for Good Manufacturing Practices for medical devices. These updates eliminate the requirement for device classification, clarify the frequency of product reviews, and introduce specific manufacturing lines for software as a medical device. Additionally, COFEPRIS has provided a new guide of questions and answers to support the interpretation and application of the revised standards. These modifications aim to align Mexico's regulations with international benchmarks, enhancing the safety, quality, and performance of medical devices in the country.
For further details, you can access the official guide here:
Learn more about COFEPRIS Mexico Medical Device Registration.
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