Health Canada has adopted the IMDRF Table of Contents (ToC) structure for medical device submissions, streamlining dossier preparation and supporting global regulatory convergence. The updated guidance outlines requirements for pre-market and post-market submissions and clarifies expectations for electronic filing, templates and documentation. Essential reading for manufacturers targeting the Canadian market.

The MHRA has published updated guidance on clinical investigations for medical devices, detailing the requirements manufacturers must meet when planning and conducting investigations in Great Britain. The update strengthens documentation expectations, safety requirements and regulatory oversight, making it essential for all manufacturers preparing UK submissions.

The European Commission has launched a Call for Evidence for its Digital Fitness Check, a major evaluation of EU digital legislation and its impact on competitiveness, innovation and administrative burden. This review is particularly relevant for medical device manufacturers facing overlapping digital, cybersecurity and data compliance obligations across EU rules.

Swissmedic has released updated guidance on the requirements for obtaining export certificates (Free Sales Certificates) for medical devices, introducing clearer rules for manufacturers on documentation, conformity evidence, product grouping, and submission procedures. The revised framework is essential for manufacturers exporting devices to global markets that require FSCs as part of their regulatory registration.

Health Canada has released Phase II of its Medical Device Establishment Licensing (MDEL) Modernization Framework, introducing enhanced compliance expectations, strengthened oversight of foreign manufacturers, updated documentation requirements and a stronger focus on post-market safety. These changes are essential for manufacturers exporting medical devices to Canada.

The FDA has issued a new draft guidance that updates the scientific principles for demonstrating biosimilarity. The document clarifies when strong analytical similarity data, supported by comparative human pharmacokinetic and immunogenicity assessments, may be sufficient to demonstrate biosimilarity without requiring a comparative clinical efficacy study. This updated approach can help manufacturers reduce development timelines and costs, while placing greater emphasis on robust analytical packages, sensitive PK study designs and a clear, risk-based justification aligned with FDA expectations.

The MHRA has released updated guidance for clinical investigations of medical devices in the UK, outlining new requirements for manufacturers, including application validation, safety reporting, UKCA/CE/CE UKNI considerations, and updated processes for studies in Great Britain and Northern Ireland. Medical device manufacturers must review these regulatory changes to maintain compliance, ensure timely clinical investigation approvals, and prepare robust technical documentation aligned with UK and EU regulatory frameworks.