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

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

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

FDA issues new guidance on biomarker validation. Learn key requirements and what manufacturers must consider for global regulatory compliance.

Notified bodies highlight key risks and proposals in the EU MDR/IVDR targeted revision, including clinical evidence, WET, and regulatory oversight.

The European Commission expands the list of implantable and Class III devices exempt from clinical investigations under MDR Article 61. Key regulatory update for manufacturers.

Discover the latest European Commission update on ERNs and what their expansion means for medical device manufacturers in rare disease areas.

Discover how MDCG 2025-9 opens a new regulatory pathway for breakthrough medical devices and IVDs under MDR and IVDR. Learn what manufacturers need to know to benefit from early designation, lifecycle evidence flexibility, and post-market strategies.

Australia's TGA has published a new version of its regulatory guidance for IVD companion diagnostics (CDx), with a direct impact on medical device manufacturers and sponsors of drugs and biologics. The document describes the legal framework, clinical and analytical assessment criteria, classification, ARTG submission requirements and the use of in-house developed CDx.