The FDA has released updated draft guidance on the eCopy Program, clarifying current requirements for electronic device submissions. As eSTAR becomes the new standard, understanding when eCopy rules still apply is critical for medical device manufacturers.

The European Commission has published the results of its second survey of Economic Operators, revealing the main challenges manufacturers face under the MDR and IVDR. The findings highlight increased administrative burden, regulatory complexity and supply chain challenges, offering important insights for companies placing devices on the EU market.

The European Commission has confirmed that four core EUDAMED electronic systems—economic operator registration, UDI and device registration, notified bodies and certificates, and market surveillance—are fully functional. This triggers mandatory transition timelines and introduces significant new obligations for medical device manufacturers.

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 TGA has released an updated consolidated guidance on the Essential Principles for medical devices, outlining key regulatory, safety, and performance requirements manufacturers must meet to supply devices in Australia. This update strengthens expectations for risk management, clinical evidence, design and manufacturing controls, and technical documentation, reinforcing compliance obligations for medical device manufacturers targeting the Australian market.

The FDA has released its final guidance on Computer Software Assurance (CSA) for production and quality system software, introducing a risk-based, streamlined approach to validating software used in manufacturing and quality operations. The updated framework helps manufacturers reduce unnecessary documentation, focus validation efforts on functions that impact product quality and patient safety, and accelerate the adoption of automated and digital technologies while remaining fully compliant with FDA requirements.