Team-NB has published a position paper calling for broader notified body access to EUDAMED and related regulatory systems to support risk-based surveillance under the MDR and IVDR.

Team-NB has highlighted the need for broader notified body access to EUDAMED vigilance, clinical investigation and performance study data to support proportionate risk-adaptive surveillance under the MDR and IVDR.

Team-NB has presented a proposal for risk-adaptive notified body surveillance under the MDR and IVDR, aiming to reduce unnecessary burden while maintaining patient safety and effective oversight.

Team-NB updates its consensus position paper on the MDR certification process, standardizing pre-application, technical file review, and EUDAMED logging.

The MHRA has updated its guidance on clinical investigations for medical devices, covering notification requirements, fees, applications, assessment, amendments, reporting and Northern Ireland requirements.

Commission Implementing Decision (EU) 2024/2120 renews the designation of UDI issuing entities for medical devices and IVDs for a further five-year period, until 27 June 2029.

MDCG 2026-5 clarifies that only the manufacturer can assign UDIs to devices placed on the EU market, even where distributors market devices under their own brand.

The European Commission has published Member State summaries of the 2025 annual reports on monitoring and on-site activities regarding notified bodies under the MDR and IVDR.

The European Commission has commissioned a study to monitor the availability of medical devices on the EU market, including dashboard data and surveys of notified bodies, economic operators and health service providers.

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.

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.

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 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 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.

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.

The FDA has announced upcoming eMDR system enhancements, including AEMS consolidation, country code requirements and IMDRF adverse event code updates.

The European Commission has published an unofficial consolidated version of the AI Act incorporating the Digital Omnibus amendments, providing an updated reference for manufacturers and other stakeholders.