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FDA has issued draft guidance on potency assessment of active immunotherapy products, covering potency assays, critical quality attributes, bioassays, physicochemical assays and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

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.

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.

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.