TEAM-NB releases Code of Conduct v5.2 for MDR/IVDR Notified Bodies. Discover key changes and how they impact medical device manufacturers.

FDA updates MDR adverse event codes under IMDRF 2025. Key changes may impact manufacturer reporting, vigilance systems, and data consistency.

Team NB explains when manufacturers can rely on non-clinical data under MDR Article 61(10) and highlights common compliance pitfalls.

FDA releases draft guidance proposing reduced regulatory requirements for certain NIOSH-approved respirators. Understand the impact on medical device manufacturers.

Team-NB releases Version 4 guidance on MDR technical documentation. Key requirements, common pitfalls, and implications for medical device manufacturers.

FDA opens consultation on a pilot program to assess artificial intelligence in early-phase clinical trials, focusing on efficiency, safety, and decision-making.

Swissmedic releases updated guidance on medical device software (MDSW), covering qualification, classification, and regulatory requirements under MDR/IVDR.

CMS proposes a new UDI measure requiring hospitals to attest use of EHR systems to capture implantable device UDIs, reinforcing FDA UDI system adoption.

MDCG publishes Revision 2 of EMDN guidance, clarifying code assignment, updates, and EUDAMED requirements under MDR and IVDR.

ENISA releases NCAF 2.0, a new framework to assess EU cybersecurity capabilities, aligned with NIS2, CRA and DORA, with focus on risk, supply chain and incident response.

MITRE releases a 2026 white paper on challenges and considerations in SBOM data normalization for medical device manufacturers.

Health Canada eliminates reconsideration requests for priority review and NOC/c decisions from April 2026. Key regulatory impacts for drug sponsors explained.

Learn about EU Batteries Regulation (EU) 2023/1542, including key requirements, scope, and timeline. What manufacturers need to know for compliance from 2025 onwards.

MDCG 2026-1 summarises accepted, partially accepted, and rejected EMDN updates from the 2025 public consultation and nomenclature working group.

EU Delegated Regulation 2026/881 defines when cybersecurity vulnerability and incident notifications may be delayed under the Cyber Resilience Act.

New EU Borderline & Classification Manual v5 (April 2026) published. Key MDR/IVDR qualification and classification examples for manufacturers.

MHRA updates its clinical investigations guidance and introduces a 2026–2027 fee waiver pilot for SMEs. Key requirements for medical device manufacturers explained.

MDCG updates medical device classification guidance under EU MDR. Key changes manufacturers must review for compliance and documentation.

MHRA clarifies alignment between the Declaration of Helsinki and amended UK Clinical Trial Regulations effective April 2026. Key impacts for sponsors and manufacturers.

MHRA updates clinical trial record retention rules to 25 years. Key implications for manufacturers, TMF management, and UK regulatory compliance.