The FDA has released new guidance on postapproval pregnancy safety studies for drugs and biologics, highlighting pregnancy registries, real-world evidence, and postmarketing surveillance expectations for manufacturers.

The EU Council and Parliament reached a provisional agreement to simplify the AI Act, including delayed deadlines for high-risk AI systems and clarifications for manufacturers.

The European Commission has adopted Implementing Regulation (EU) 2026/977, introducing new conformity assessment requirements for notified bodies under the MDR and IVDR.

The European Commission has updated the MIR 7.3.1 vigilance reporting forms under the EU MDR and IVDR. Manufacturers should verify accepted versions and updated XSD/XSL files.

The FDA has launched a pilot program introducing one-day inspectional assessments across medical products, biologics, clinical research, and food sectors to support more targeted and efficient oversight.

MedTech Europe has published its position on the MDR/IVDR revision, supporting simplification measures while warning about new burdens for manufacturers, AI compliance challenges, cybersecurity reporting, and single-use device reprocessing.

Health Canada has updated its guidance for Class II, III, and IV private label medical device licence applications. Learn what manufacturers need to know about REP submissions, MDSAP requirements, documentation expectations, and compliance implications.

Health Canada now requires mandatory use of the Regulatory Enrolment Process (REP) and CESG for Class II–IV medical device submissions. Learn what manufacturers must do and how the new IMDRF ToC requirements may impact regulatory workflows.

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FDA releases draft guidance proposing reduced regulatory requirements for certain NIOSH-approved respirators.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.