EU Health Technology Assessment
Material regulatory developments from European Commission SANTE are tracked daily by Cresthaven Analytics. Over the last 90 days, 10 material briefs relevant to professionals operating in the healthcare & life sciences sector have been published below. Each brief is sourced directly from the primary regulatory feed, summarized for institutional readers, and scored for materiality.
Recent material activity
A selection of recent published briefs; this is not a complete archive.
European Commission publishes three stakeholder input templates for joint clinical assessments under EU HTA Regulation
The European Commission's Directorate-General for Health and Food Safety published three templates on September 14, 2026 to structure written input from patients, carers, and clinical experts during joint clinical assess…
Read the full EU Health Technology Assessment brief →European Commission updates the official list of ongoing joint clinical assessments under the EU HTA Regulation
The European Commission's Directorate-General for Health and Food Safety published an updated list of ongoing joint clinical assessments on September 10, 2026. The update reflects the current pipeline of products under c…
Read the full EU Health Technology Assessment brief →European Commission publishes joint clinical assessment report on onasemnogene abeparvovec for spinal muscular atrophy
The European Commission published a joint clinical assessment report on onasemnogene abeparvovec (Itvisma) on September 7, 2026, covering this advanced therapy medicinal product for spinal muscular atrophy. EU Member Sta…
Read the full EU Health Technology Assessment brief →European Commission updates JCA early-information guidance and launches eligibility checker for health technology developers
On August 19, 2026, the European Commission published updated guidance for health technology developers submitting early information for joint clinical assessments of medicinal products. The update aligns with revised EM…
Read the full EU Health Technology Assessment brief →European Commission publishes eligibility-check tool for Joint Clinical Assessment under the EU HTA Regulation
The European Commission published an interactive eligibility-check tool on August 3, 2026 to help determine whether a medicinal product qualifies for Joint Clinical Assessment under the EU Health Technology Assessment Re…
Read the full EU Health Technology Assessment brief →European Commission publishes AI use principles for Joint Clinical Assessment dossier preparation under EU HTA Regulation
The European Commission's Health directorate published general principles on July 16, 2026 governing the use of artificial intelligence in preparing Joint Clinical Assessment dossiers. The guidance sets baseline expectat…
Read the full EU Health Technology Assessment brief →European Commission updates submission request template for medical devices under EU MDR
The European Commission's health directorate published an updated submission request template for medical devices on July 16, 2026. The update revises the standardized format that manufacturers and notified bodies use wh…
Read the full EU Health Technology Assessment brief →European Commission publishes joint clinical assessment reports for two new lung cancer medicines under the EU HTA Regulation
On July 8, 2026, the European Commission published joint clinical assessment reports for two new lung cancer medicines under the EU Health Technology Assessment Regulation. These reports establish a common EU-level clini…
Read the full EU Health Technology Assessment brief →European Commission updates the active list of joint clinical assessments under the EU HTA Regulation
The European Commission published an updated list of joint clinical assessments on July 8, 2026, under the EU Health Technology Assessment Regulation. The update reflects the current pipeline of products subject to manda…
Read the full EU Health Technology Assessment brief →European Commission publishes delegated acts establishing regulatory pathways for well-established medical device technologies under the EU MDR
The European Commission published delegated acts on June 29, 2026 defining the regulatory treatment of well-established technologies under the EU Medical Devices Regulation. The acts create differentiated conformity asse…
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