ISO 10993-6:2026 and ISO 10993-7:2026 update biocompatibility testing with new definitions, risk-based approaches, and expanded test methods including histopathology and ethylene oxide residual analysis. ISO 14155:2026 replaces the 2020 version with immediate effect, strengthening clinical investigation requirements including risk management, Clinical Event Committees, and Data Monitoring Committees. Manufacturers and sponsors must update QMS and clinical documentation accordingly.

The EMA breakthrough devices pilot program 2026 introduces an EU regulatory pathway for breakthrough medical devices and IVDs with high novelty and positive clinical impact. Supported by MDCG 2025-9 and the European Commission proposal 2025/0404, it enables adaptive certification under MDR Article 52a and IVDR Article 48a. Manufacturers must obtain expert panel opinions to qualify, gaining early scientific advice and regulatory support while maintaining EU safety and performance standards.

EU Commission Rev.2 Q&A 2026 clarifies obligations for manufacturers and authorized representatives to notify authorities about supply interruptions or discontinuations of medical devices and IVDs. Key updates include expanded guidance on assessment indicators (Q9.2) and a decision tree tool to support risk assessment. Staying compliant with Article 10a MDR/IVDR ensures uninterrupted market access and patient safety.

FDA’s 2026 PPI guidance encourages voluntary collection of patient preference information across the total product life cycle. Devices with direct patient interfaces, subjective outcomes, or high risks benefit most. PPI supports premarket submissions, labeling, and post-market evaluation. Guidance aligns with EU MDR/IVDR PMCF/PMPF principles, helping assess patient risk tolerance and benefit-risk trade-offs. Manufacturers should collect scientifically valid PPI to inform regulatory decision-making and enhance patient-centered device development.

The MDA’s 2026 Second Edition guidance clarifies the definition of medical devices, including accessories, components, and spare parts. It helps manufacturers, importers, and healthcare providers identify which items require registration under the Medical Device Act 2012 (Act 737) and associated regulations. Compliance with this guidance ensures proper classification, regulatory adherence, and smoother market access in Malaysia.

The MDA’s 2026 Third Edition guidance clarifies the import and supply of unregistered medical devices under Special Access Exemption (SAE). Key updates include detailed eligibility, Medcast application process, labelling, record-keeping, and post-handling requirements. The guidance ensures timely access to critical devices while maintaining compliance with Malaysian regulations and patient safety. All healthcare providers and industry stakeholders must obtain SAE approval before importing or supplying unregistered devices.

The EU Notified Bodies Survey 2026 shows MDR and IVDR certification trends, including application volumes, key compliance challenges, and Class C IVD deadlines. Manufacturers must address incomplete submissions, device misclassification, and other procedural issues to meet EU regulatory requirements. Planning early and engaging proactively with Notified Bodies is essential for timely market access.

SWISSMEDIC SWISSDAMED registration 2026 mandates all IVDs, medical devices, and MD-DEVIT products be registered by 1 July 2026, with a transition period until 31 December 2026. Economic operators must ensure compliance, update QMS procedures, and coordinate registration with EU EUDAMED timelines. Accurate and timely registrations reduce risk of audits and inspections, ensuring devices are market-ready in Switzerland and aligned with EU regulations.

COFEPRIS electronic notifications 2026 allow regulated entities in Mexico to receive official communications via email, covering updates on procedures, administrative requirements, and final resolutions. Businesses must complete the official authorization form and maintain accurate email addresses. The system improves communication speed, traceability, and legal certainty, reducing administrative backlog and enhancing compliance reliability for industries such as pharmaceuticals, medical devices, food, and cosmetics.