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.

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.

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.

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.

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.

The MHRA has published updated guidance on how manufacturers can request regulatory advice meetings for medical and IVD devices in the UK. This service helps clarify complex regulatory questions but excludes product-specific consultancy. Discover fees, scope, limitations, and how to apply.