FDA Recognition List 065 updates biocompatibility standards, including ISO 10993-4 Amendment 1 and multiple ASTM revisions. Impact for manufacturers.

New Team-NB position paper clarifies IVDR expectations for safety, risk assessment and performance evaluation of reagent devices used in combination.

The European Commission adopts Implementing Decision (EU) 2026/193, updating harmonised standards under MDR (EU) 2017/745.

The MHRA has published its February 2026 Guide on Defective Medicinal Products. Learn what UK manufacturers and marketing authorisation holders must do regarding defect reporting, recalls, and DMRC obligations.

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

The FDA has published a draft guidance adopting the ICH E22 guideline on Patient Preference Studies. Learn what this means for manufacturers involved in global development programmes.

Swissmedic has published version 1.2 of its guidance on the Medical Device Publication Service, clarifying how Field Safety Corrective Actions and Field Safety Notices are published and accessed.

Swissmedic has published version 19.0 of its Formal Requirements Guidance, applicable from February 2026. Learn what manufacturers and combination product developers need to prepare for.

The FDA has issued an updated guidance on Computer Software Assurance for production and quality management system software, aligned with the new QMSR and ISO 13485.

EUDAMED Production v2.22.0 introduces EMDN versioning, improved traceability, and DTX updates. Learn what this means for manufacturers.

Swissmedic publishes updated EUDAMED UDI enumerations (v2.18.0). What this means for manufacturers preparing UDI, device and certificate data submissions.

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

FDA issues final guidance on cybersecurity in medical devices, outlining QMS, premarket documentation, and Section 524B requirements for manufacturers.

FDA implements Compliance Program 7382.850, aligning medical device inspections with the Quality Management System Regulation and ISO 13485.

The European Commission has adopted Commission Implementing Decision (EU) 2026/197 of 28 January 2026, amending Implementing Decision (EU) 2021/1195 by adding new references to harmonised standards supporting Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). The Decision was published in the Official Journal of the European Union on 30 January 2026 and entered into force on the same day.

New EU-U.S. Data Privacy Framework FAQ impacts data transfers to U.S. vendors. What this means for medical device manufacturers in 2026.

MedTech Europe’s MDR/IVDR reform proposals remain key as the EU prepares its 2026 legislative update. Find out what this means for manufacturers.

New MHRA guidance summarises UK conformity routes for all medical device classes. Essential for UKCA compliance and UK MDR planning.

The FDA has issued updated guidance on Clinical Decision Support (CDS) software, clarifying which software functions are excluded from the medical device definition under U.S. law.

The TGA has updated its guidance on Certificates of Free Sale and Export Certificates for medical devices. Key changes for EU manufacturers exporting via Australia.