Swissmedic has updated its checklist for materiovigilance inspections in hospitals, covering medical devices and IVDs, quality management, reporting, traceability, FSN/FSCA processes and staff training.

The European Commission expert panel has issued a CECP scientific opinion on a Class III implantable dual-chamber leadless pacemaker, highlighting clinical evidence, benefit-risk assessment and PMS considerations.

The MHRA has updated its guidance on the management and use of in vitro diagnostic point-of-care test devices, including POCT services in primary and secondary care settings.

MedTech Europe has responded to the European Commission’s Call for Evidence on future European Partnerships implemented as Joint Undertakings under the next Multiannual Financial Framework.

The MHRA has updated its list of UK approved bodies authorised to undertake conformity assessments for medical devices under the UK MDR 2002.

Swissmedic has updated its information sheet on clinical investigations of medical devices, including approval procedures, ISO 14155, category C investigations, reporting duties and IMDRF adverse event terminology.

From 1 July 2026, certain medical devices supplied in Australia must meet TGA Unique Device Identification requirements, starting with Class IIb and Class III devices.

FDA CBER has updated SOPP 8704 on MDUFA user fee payments and billing activities, including electronic payments, payment verification, user fee holds, refunds and establishment registration fees.

NBCG-MED has published operational elements for the application of hybrid audits to QMS assessments under the MDR and IVDR, including on-site requirements, ICT use and audit planning.

The European Commission has published a draft implementing regulation amending common specifications for certain Class D IVDs under the IVDR, including HEV, Toxoplasma gondii, Plasmodium and arboviruses.

Swissmedic has updated its information sheet on IVD performance studies, covering approval procedures, reporting duties, ISO 20916, category C studies and Swissmedic surveillance.

The MDCG has updated its guidance on standardisation for medical devices, covering harmonised standards, presumption of conformity, state of the art, common specifications and EU case law.

The MHRA has updated its guidance on clinical investigations for medical devices, including applications, assessment timelines, amendments, reporting requirements and fee waiver information.

The CD-P-TO has published a position paper on the MDR and its implications for the substances of human origin sector, focusing on Article 5(5), RUO products and CE-marked devices used beyond their intended purpose.

Swissmedic has updated its swissdamed User Guide for the UDI Devices Module, including guidance on UDI registration, market status, M2M, Master UDI-DI and legacy devices.

The European Commission has published the 20th Notified Body survey results under the MDR and IVDR, with data status 28 February 2026.

FDA has updated its technical specifications guidance on submitting next-generation sequencing protocols, data and analyses to the Division of Antivirals.

NIST has published a news release on a mathematical proof supporting the transition from a “one and done” AI security model to continuous monitoring and updating.

The European Commission has published the third EO survey results on the availability of medical devices and IVDs on the EU market, with data status 31 October 2025.

Team-NB has published a proposal for a risk-adaptive surveillance system under the MDR, covering surveillance audits, unannounced audits, technical documentation sampling and PSUR updates.