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