The Council for International Organizations of Medical Sciences (CIOMS) has published Version 10 of its Glossary of ICH Terms and Definitions, consolidating terminology from current ICH guidelines and supporting greater consistency in regulatory communication across the life sciences sector.

The MHRA has published the Phase 2 report of its AI Airlock programme, highlighting regulatory challenges related to AI medical devices, AI-powered IVDs, performance evaluation, post-market surveillance and lifecycle change management.

The WHO has adopted revised recommendations for International Biological Reference Standards (WHO IBRS), introducing updated guidance on commutability, calibration, secondary standards and International Units. Learn what IVD and biological product manufacturers need to know.

MedTech Europe has published new recommendations for the MDR/IVDR revision, calling for a more proportionate regulatory framework, support for innovation, and improved access to in vitro diagnostics across Europe.

MedTech Europe responds to the EU Cybersecurity Act consultation, highlighting key implications for medical device and IVD manufacturers, including certification, vulnerability management, and supply chain security.

Swissmedic highlights the updated MIR template version 7.3.1 for MDR/IVDR vigilance reporting. Learn how the new requirements impact medical device and IVD manufacturers.

The Australian TGA has updated its guidance to recognise UK Approved Bodies as comparable overseas regulators, potentially simplifying ARTG submissions for medical device and IVD manufacturers.

The European Commission has adopted Regulation (EU) 2026/977 introducing new MDR and IVDR rules for notified body timelines, quotations, transparency and re-certification activities.

The European Commission has adopted Implementing Regulation (EU) 2026/977, introducing new conformity assessment requirements for notified bodies under the MDR and IVDR.

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

Swissmedic updates guidance on medical device incident reporting. Key timelines, obligations, and implications for manufacturers explained.

Latest European Commission data shows MDR and IVDR application volumes, certification timelines, and submission quality based on the 18th Notified Body survey (October 2025 data).

IMDRF publishes final guidance on the selection and consistent use of adverse event terminology (AET) codes for medical devices and IVDs.

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The TGA has released Version 6.0 of its ARTG variation guidance. Learn what manufacturers and sponsors need to know to stay compliant with ARTG requirements.

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 newly published ANVISA manual provides updated guidance for the regularisation of medical devices and in vitro diagnostic products in Brazil. Covering topics such as device classification, documentation, GMP certification, and use of the Solicita system, this manual is essential for medical device and IVD manufacturers looking to expand into Brazil. By ensuring regulatory compliance, manufacturers can achieve faster access to Brazil’s large and growing healthcare market.

A ISO e a IEC estão a desenvolver e atualizar várias normas internacionais que afetam diretamente o setor dos dispositivos médicos e IVD, incluindo temas como qualidade, cibersegurança e software médico. Estas normas, como a ISO 13485, ISO/IEC 82304-2 e IEC 81001-5-1, reforçam o compromisso global com a segurança, interoperabilidade e inovação responsável.