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

The European Commission has updated the MIR 7.3.1 vigilance reporting forms under the EU MDR and IVDR. Manufacturers should verify accepted versions and updated XSD/XSL files.

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.

MedTech Europe has published its position on the MDR/IVDR revision, supporting simplification measures while warning about new burdens for manufacturers, AI compliance challenges, cybersecurity reporting, and single-use device reprocessing.

Health Canada has updated its guidance for Class II, III, and IV private label medical device licence applications. Learn what manufacturers need to know about REP submissions, MDSAP requirements, documentation expectations, and compliance implications.

Health Canada now requires mandatory use of the Regulatory Enrolment Process (REP) and CESG for Class II–IV medical device submissions. Learn what manufacturers must do and how the new IMDRF ToC requirements may impact regulatory workflows.

TEAM-NB releases Code of Conduct v5.2 for MDR/IVDR Notified Bodies. Discover key changes and how they impact medical device manufacturers.

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

FDA releases draft guidance proposing reduced regulatory requirements for certain NIOSH-approved respirators. Understand the impact on medical device manufacturers.

Learn about EU Batteries Regulation (EU) 2023/1542, including key requirements, scope, and timeline. What manufacturers need to know for compliance from 2025 onwards.

MDCG 2026-1 summarises accepted, partially accepted, and rejected EMDN updates from the 2025 public consultation and nomenclature working group.

New EU Borderline & Classification Manual v5 (April 2026) published. Key MDR/IVDR qualification and classification examples for manufacturers.

MHRA updates its clinical investigations guidance and introduces a 2026–2027 fee waiver pilot for SMEs. Key requirements for medical device manufacturers explained.

MDCG updates medical device classification guidance under EU MDR. Key changes manufacturers must review for compliance and documentation.

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

MHRA releases updated 2026 guidance on clinical investigations in Great Britain. Key regulatory impacts for medical device manufacturers under UK MDR.

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

The FDA launches the READI-Home Innovation Challenge to support medical devices aimed at reducing hospital readmissions through home-based care solutions.

Health Canada clarifies when medical device changes require licence amendments. Key insights for manufacturers on risk, software, and design changes.

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