The FDA has launched a pilot program introducing one-day inspectional assessments across medical products, biologics, clinical research, and food sectors to support more targeted and efficient oversight.

FDA updates MDR adverse event codes under IMDRF 2025. Key changes may impact manufacturer reporting, vigilance systems, and data consistency.

MHRA clarifies alignment between the Declaration of Helsinki and amended UK Clinical Trial Regulations effective April 2026. Key impacts for sponsors and manufacturers.

Swissmedic publishes updated CAPA plan requirements for medical devices, effective April 2026. Key impacts for manufacturers and compliance strategies explained.

The European Commission releases EUDAMED v2.25.2 with new validation rules, certificate controls, and API access. Key implications for medical device manufacturers.

TGA publishes updated guidance on software-based medical devices. Key regulatory implications for manufacturers supplying SaMD in Australia.

ANVISA publishes draft rules on UDI data transmission and SIUD management in Brazil. Learn how the new requirements impact medical device manufacturers.

Swissmedic publishes eIAM Portal Administrator guidance version 3.4, effective February 2026. Learn what this means for manufacturers using Swiss eGov services.

ANVISA publishes final version (v1.3) of its Medical Device Registration Manual. See what manufacturers need to know for regulatory submissions in Brazil.

New MDCG guidance on post-market surveillance provides clearer operational expectations for manufacturers under MDR and IVDR. PMS plans must now be more proactive, structured, and integrated into the QMS.

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 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.

Swissmedic’s updated guidance on PSUR Signal Management sets a higher standard for pharmacovigilance in Switzerland. By aligning with EU Regulation 2019/6 and VICH GL 29, it requires manufacturers to strengthen PSUR reporting, signal evaluation, and safety data traceability. For medical device and IVD producers, this shift underscores the importance of robust post-market surveillance and regulatory readiness. Smart MDR supports companies in navigating these evolving frameworks efficiently and confidently.

The FDA has released a draft guidance aligning U.S. Quality Management System (QMS) requirements with ISO 13485:2016. This change simplifies compliance for medical device and IVD manufacturers and distributors, ensuring global harmonization and streamlined FDA premarket submissions effective February 2026.

The AI Airlock initiative, launched by the MHRA, is an innovative regulatory sandbox designed to support the development and evaluation of Artificial Intelligence medical devices (AIaMD). This controlled regulatory environment allows manufacturers of AI-based medical technology to test compliance approaches, clinical evidence and algorithmic validation prior to formal submission. With a focus on adaptive machine learning models, algorithmic security and continuous monitoring, AI Airlock represents a strategic opportunity to accelerate market access with UKCA compliance.

The MDCG has published guidance 2025-4, which clarifies the responsibilities of manufacturers of software as a medical device (MDSW) and operators of online platforms that make these apps available in the European Union. The guidance addresses the application of the MDR, the IVDR and the Digital Services Act (DSA), and reinforces labeling, traceability and transparency requirements. Smart MDR supports manufacturers and platforms in regulatory compliance and adaptation to the new obligations of the European digital market.