This week in global device regulatory news, Team-NB issued a position paper on how the EU AI Act meshes with MDR/IVDR, the UK MHRA refreshed its MORE guidance ahead of new post-market-surveillance rules, Swissmedic adopted the EU’s MIR Form v7.3.1 for serious-incident reporting, Brazil’s Anvisa opened a consultation on single-use device processing practices, and China’s NMPA updated its catalogue of devices exempt from clinical evaluation.
Opinions from Team-NB are published regarding the implementation and application of the EU AI Act (Regulation (EU) 2024/1689), with a focus on the interface and overlap with MDR and IVDR. The EU AI Act entered into force on 01 August 2024 and introduced a risk-based approach to determine the level of scrutiny for AI systems being placed on the Union market or being used in the Union. According to Article 113 (c) (AIA), the high-risk scope under Article 6(1) will become applicable on 02 August 2027.
From that date onward, newly introduced or legacy medical devices undergoing a significant change (Art. 111 (2)) and fulfilling the aforementioned conditions (i.e., requirement for third party conformity assessment and use as safety component or as a device itself) will have to comply with provisions of the AI Act. This position paper provides an overview of the Team-NB perspective on the challenges of the AI Act with particular attention to its implementation.
In summary, NB team highlights the necessary completion of existing challenges, such as for clear definitions, timely national laws, availability of designating authorities, robust data security, integrated reporting systems, consideration of fundamental rights, and availability of harmonized standards are essential for smooth and effective conformity assessments and ensuring access to advanced medical technology.
Learn more about EU MDR and IVDR consulting.
MHRA has introduced new Post-Market Surveillance (PMS) requirements under SI 2024/1368 for devices marketed in Great Britain (England, Scotland, Wales), becoming effective 16 June 2025. These PMS requirements widely align to EU PMS requirements established under MDR/IVDR. Generally, all PMS systems include reactive and proactive measures to be taken by manufacturers. These PMS activities are linked to post-market clinical follow-up (PMCF, for medical devices) or post-market performance follow-up (PMPF, for IVDs) activities and trend reporting.
For trend reporting related to vigilance activities, the UK has created a web-based system, the Manufacturer’s Online Reporting Environment (MORE). The new Manufacturer’s Online Reporting Environment (MORE) Guidance now describes how to report Manufacturer Incident Reports (MIR) and Field Safety Corrective Actions (FSCA) through the MORE platform, e.g., where additional information should be included. The Great Britain (GB) data schemas will be live in MORE starting 16 June 2025 and the new MHRA process and vigilance reporting activities will be mandatory from 17 October 2025.
Learn more about MHRA UK Medical Device Registration & Approval.
Swissmedic has aligned its vigilance requirements with the EU by adopting the European Commission’s new Manufacturer Incident Report (MIR) Form v7.3.1, published on 5 May 2025. Key points:
Since the Mutual Recognition Agreement (MRA) with the EU lapsed, Switzerland is treated as a “third country,” yet Swiss vigilance rules continue to mirror EU legislation:
Where to get the form & guidance:
By adopting the updated EU form and issuing local guidance, Swissmedic aims to maintain regulatory convergence while ensuring incident data meet Swiss requirements.
Learn more about Switzerland Medical Device Registration.
On May 13, 2025, Anvisa launched a targeted consultation on single-use medical devices and good processing practices. The consultation is open exclusively to members of the National Health Surveillance System and will remain available for 30 days.
Stakeholders are invited to review and contribute to the proposed updates, aiming to enhance safety and regulatory clarity around the reuse and processing of such devices.
Learn more about ANVISA Brazil Medical Device Regulations.
The National Medical Products Administration (NMPA) has released the updated 2025 Catalogue of Medical Devices Exempt from Clinical Evaluation (Notice No. 19 [2025]). This revision replaces the 2023 version and reflects updates aligned with Order No. 47 of the Administrative Measures for the Registration and Filing of Medical Devices.
The new catalogue, effective immediately as of May 13, 2025, aims to streamline the registration process for eligible devices and improve regulatory efficiency.
Learn more about China Medical Device Registration & Approval.
Browse our news hub featuring company announcements, regulatory updates, and industry insights to keep you informed and ahead of the curve.
Whether looking for more information or ready to partner with us, we're here to guide you through every step of the regulatory process.
Contact us