Swissmedic has updated its Formal requirements guidance document to version 22.0, setting out administrative and submission requirements for applications, variations, medicinal product information, packaging, combination products, DMF/ASMF and special product types.

The TGA has updated its guidance on performance requirements and risk mitigation for COVID-19 rapid antigen tests, covering analytical and clinical evidence, self-test usability, IFU requirements, software, COR approvals and post-market monitoring.

MedTech Europe and Mecomed have published considerations on the impact of the EU MDR and IVDR transition on international registrations in the Middle East and Africa, calling for a harmonised and risk-based approach to change management.

EMA has updated the list of CECP opinions issued by Expert Panels for medical devices undergoing conformity assessment, supporting transparency in the Clinical Evaluation Consultation Procedure.

Anvisa has published two guidance manuals for the regularization of IVD devices and notification of risk class I and II medical devices, aiming to improve dossier quality and reduce technical requirements and rejections.

Anvisa has published a manual on the notification process for risk class I and II medical devices in Brazil, covering company regularization, product classification, Solicita electronic submission, documentation requirements and secondary petitions.

The European Commission is considering allowing electronic instructions for use for all professional-use medical devices and has launched a survey for healthcare professionals and healthcare institutions in the EU.

FDA has published a discussion paper seeking stakeholder feedback on regulatory considerations for generative AI-enabled medical devices, including risk assessment, premarket evaluation, benchmarking, clinical confirmation, postmarket monitoring and foundation models.

FDA has issued draft guidance on potency assessment of active immunotherapy products, covering potency assays, critical quality attributes, bioassays, physicochemical assays and product-specific considerations.

Swissmedic has published version 6.0 of its technical interpretation on the container-specific guarantee of starting material identity, defining requirements for suppliers, GMP controls, labelling, certificates of analysis and inspections.

The MHRA-NICE Real-World Evidence Scientific Dialogue will now accept applications relating to real-world evidence and medical devices, with Approved Bodies represented in relevant workshops.

ISO 10993-3:2026 has been published, updating guidance for the evaluation of genotoxicity, carcinogenicity, reproductive toxicity and developmental toxicity in the biological evaluation of medical devices.

Team-NB, TÜV Verband and TIC Council highlight the importance of maintaining strict, risk-based oversight in the MDR/IVDR revision to protect patient safety.

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.