Anvisa has announced that registration requests for international manufacturers of risk class I and II medical devices, including IVDs, must now be submitted electronically through the Solicita system using subject code 80326.

MHRA has published the fifth edition of its safety guidelines for MRI equipment in clinical use, covering MRI hazards, exposure management, governance, controlled access, patient management, equipment lifecycle, incidents and staff training.

EMA held a multistakeholder workshop on supporting innovation in cardiovascular medicines and medical devices in the EU, covering unmet needs, regulatory science, AI, digital technologies and emerging therapies.

Swissmedic has updated its information sheet on procurement of medical devices in healthcare institutions, covering conformity evidence, swissdamed registration, CH-REP and importer information, UDI, implant cards and non-conforming devices.

The TGA has opened a consultation on proposals to improve public information sharing about the safety, quality and performance of medical devices after post-market reviews or investigations.

A regulatory affairs review highlights how MDSAP methodology can help French and EU medical device manufacturers structure quality management, internal audits and conformity control under the EU MDR.

The EU Commission 20th Notified Body Survey shows a slight decline in MDR applications and continued growth in IVDR applications, highlighting ongoing certification pressures under the MDR and IVDR.

MHRA has updated its guidance on submitting clinical investigation proposals, covering GB and Northern Ireland requirements, IRAS submission, supporting documentation, fees, device evidence, software, biological safety and sterilisation.

FDA has issued updated guidance on 510(k) submissions for hemodialysis blood tubing sets, covering device description, performance testing, biocompatibility, sterility, shelf life, packaging and labeling.

IMDRF has published final principles on Predetermined Change Control Plans for medical device software, covering PCCP elements, risk-based change control, impact assessment, benefits and challenges.

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Team-NB has published a position paper calling for broader notified body access to EUDAMED and related regulatory systems to support risk-based surveillance under the MDR and IVDR.

Anvisa has launched Call Notice 5/2026 to select up to 10 innovative medical device projects for regulatory evaluation and continuous dialogue in Brazil.

FDA has issued guidance on applying human factors and usability engineering to medical devices, focusing on user interface design, use-related risk management, critical tasks and human factors validation testing.

Swissmedic has updated its guidance on export certificates for medical devices, including eligibility, ordering requirements, product lists, CE conformity documentation, swissdamed registration and fees.

The TGA has updated its guidance on how medical device applications are selected for audit before inclusion in the ARTG, including mandatory audits, non-mandatory audit criteria, regulatory reforms, UDI and post-market signals.

The updated MDSAP Audit Approach document, MDSAP AU P0002.011, provides detailed instructions for conducting process-based MDSAP audits and integrates the former Audit Model and Process Companion documents.

NIST AI 600-1 provides a Generative AI Profile for the AI Risk Management Framework, identifying key GAI risks and suggested actions to govern, map, measure and manage them.

Team-NB has highlighted the need for broader notified body access to EUDAMED vigilance, clinical investigation and performance study data to support proportionate risk-adaptive surveillance under the MDR and IVDR.

Team-NB has presented a proposal for risk-adaptive notified body surveillance under the MDR and IVDR, aiming to reduce unnecessary burden while maintaining patient safety and effective oversight.

ISO 14155:2026 specifies good clinical practice for the design, conduct, recording and reporting of clinical investigations of medical devices involving human subjects.