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.

FDA’s Breakthrough Devices Program provides expedited interaction and prioritized review for eligible medical devices intended to treat or diagnose life-threatening or irreversibly debilitating diseases or conditions.

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.

WHO has published policy considerations to improve access to refractive error care, focusing on spectacles, service access, workforce capacity, population education, cost reduction, surveillance and research.

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.

The preliminary draft 2027 Annual Union Work Programme for European standardisation includes a standardisation request for medical devices and IVDs under Regulations (EU) 2017/745 and 2017/746.

IMDRF has published its 2026 Document Implementation Report, providing the self-identified implementation status of IMDRF technical documents across member jurisdictions.

The TGA has updated its guidance on clinical performance and risk mitigation requirements for IVD self-tests for chlamydia, gonorrhoea and syphilis, including study design, usability, IFU and post-market monitoring expectations.

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.

Health Canada has announced changes to the Special Access Program application process for medical devices, including a new accessible application form, secure submission method and mandatory use from 1 February 2027.

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.

EMA has updated its Q&A on practical arrangements for the companion diagnostics consultation procedure by notified bodies, covering letters of intent, IRIS submissions, rapporteur appointment, pre-submission interactions, eSubmission and fees.

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.