Pure Global Editorial Team

The European Commission has published Implementing Decision (EU) 2026/1231, updating the list of harmonized standards across several medical device areas. Manufacturers should review technical documentation, declarations, test documentation, and internal standards registers against the revised list.

MDCG 2021-5 Rev.1 clarifies the transition from EC REP to EU REP after EN ISO 15223-1:2021/A1:2025. Manufacturers may use EC REP, EU REP, or both symbols during a 60-month transition ending on 17 June 2031, provided Authorized Representative information remains clear and intelligible.

Malaysia's Medical Device Authority (MDA) and Japan's Ministry of Health, Labour and Welfare (MHLW) have signed a Memorandum of Cooperation (MoC) in Tokyo, marking a significant step toward regulatory alignment and closer collaboration between the two countries. The agreement lays the groundwork for more efficient medical device registration, enhanced information sharing, and improved post-market surveillance frameworks. Manufacturers operating in both markets could benefit from greater regulatory predictability and streamlined market access as the partnership develops.

The U.S. FDA human factors guidance 2026 update revises requirements for human factors information in medical device marketing submissions, including 510(k), De Novo, and PMA pathways. It introduces new risk-based Human Factors Submission Categories 1–3, expands examples for modified devices, and clarifies expectations for usability validation. Sponsors must assess use-related risks, device complexity, and interface changes when determining submission requirements to ensure compliance with FDA usability engineering expectations.

The Swissmedic swissdamed fees 2026 update introduces mandatory medical device registration in Switzerland from 1 July 2026 under MedDO and IvDO. Devices must be registered in swissdamed and will be subject to annual fees based on UDI-DI counts, with a CHF 200 base fee and CHF 20 per additional device, capped at CHF 10,000 per manufacturer. The regulation aligns Swiss medical device registration with lifecycle-based compliance and introduces a transition period until 31 December 2026.

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Mexico has published NOM-137-SSA1-2025, a major overhaul of its medical device labeling standard that introduces stricter traceability requirements, expanded use of international symbols, and stronger sterility labeling expectations. Foreign manufacturers and importers will feel the greatest impact, with likely updates needed across labels, IFUs, and contra-labeling processes. With mandatory compliance kicking in on May 14, 2027, the roughly 360-day transition window makes now the right time to start your gap assessment.

The European Commission has published Regulation (EU) 2026/977, introducing standardized requirements for Notified Bodies that promise to bring much-needed consistency to EU MDR and IVDR conformity assessments. Manufacturers can expect clearer timelines, including a maximum of 90 days for technical documentation assessment and greater cost transparency in NB quotations. With the regulation applying from February 2027, now is the time to start preparing.

The European Commission has released the third 2026 update to the Manufacturer Incident Report (MIR) form version 7.3.1 (SB-11154), addressing technical bugs and compatibility issues affecting electronic vigilance submissions to EU and non-EU regulatory databases. While the changes may seem minor, manufacturers who don't update their workflows risk XML upload failures, rejected submissions, and potential audit nonconformities. Read on to learn what's changed and the concrete steps your regulatory team should take now to stay compliant.

Malaysia’s Medical Device Authority (MDA) has published the first edition of MDA/GD/0072 Change Management for Registered Medical Devices, which will replace MDA/GD/0020 following the official launch of MedCAST 3.0. Until implementation takes effect, the current change notification guidance remains applicable. Companies should review the new guidance and prepare for upcoming regulatory process changes.

Malaysia’s MDA updated the Requirements for Labelling of Medical Devices in 2026 by revising Clause 4.8(e) for foreign manufacturers. Under the new requirement, manufacturer name and address remain mandatory, while contact details such as email, phone number, or website address for technical assistance are now optional. The update provides greater flexibility for medical device labelling compliance in Malaysia.

Singapore and China have renewed their health products regulatory partnership, expanding collaboration into cutting-edge therapies including cell, tissue, and gene therapy products. The updated MOU between Singapore's HSA and China's NMPA aims to streamline regulatory pathways and accelerate patient access to innovative treatments across both countries. For healthcare companies and researchers, the strengthened agreement could unlock new cross-border opportunities in one of the world's fastest-growing life sciences markets.

The CMS and FDA RAPID Coverage Pathway 2026 accelerates Medicare access to breakthrough medical devices by aligning regulatory approval and coverage decisions. It enables early CMS–FDA collaboration, shared clinical evidence, and same-day proposed coverage decisions upon FDA authorization. Eligible devices include certain Class II and Class III breakthrough devices studied in Medicare populations, reducing coverage timelines from over a year to approximately two months.

Swissmedic’s 2026 focus campaign targets post-market surveillance documentation for randomly selected Class IIa, IIb, and III medical devices in Switzerland. Manufacturers and Swiss Authorized Representatives must provide PMS, PSUR, PMCF, and vigilance data for review. The campaign strengthens regulatory oversight of higher-risk devices and ensures compliance with Swiss post-market surveillance requirements.

The EU MDCG 2026 updates bring important clarifications to medical device classification under MDR (EU) 2017/745 and revisions to the European Medical Device Nomenclature (EMDN). These changes improve guidance on classification rules, intended use interpretation, and the correct assignment of EMDN codes used in EUDAMED and technical documentation.

The EU MDR IVDR Borderline Manual 2026 (Version 5) clarifies borderline products—items that may or may not qualify as medical devices. Classification depends on intended use and alignment with MDR (EU) 2017/745 or IVDR (EU) 2017/746. The update adds new

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.