HTA Coordination Group Adopts Guiding Principles on Data Transparency
The EU HTA Coordination Group has adopted new guiding principles on data transparency, clarifying confidentiality expectations for Joint Clinical Assessments involving medical devices and IVDs.
MHRA Updates Guidance on Clinical Investigations and Introduces 2026–2027 Fee Waiver Pilot
MHRA updates its clinical investigations guidance and introduces a 2026–2027 fee waiver pilot for SMEs. Key requirements for medical device manufacturers explained.
MHRA Issues Updated Guidance on Submitting Clinical Investigation Proposals
MHRA releases new 2026 guidance on clinical investigation submissions via IRAS. Key requirements, timelines, and implications for manufacturers.
European Reference Networks Continue to Expand: What It Means for Medical Device Manufacturers
Discover the latest European Commission update on ERNs and what their expansion means for medical device manufacturers in rare disease areas.
ANVISA publishes final version (v1.3) of the Medical Device Registration Manual – January 2026
ANVISA publishes final version (v1.3) of its Medical Device Registration Manual. See what manufacturers need to know for regulatory submissions in Brazil.