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Commission updates joint scientific consultation guidance to add 'watcher' role for HTA

🇪🇺 European Commission (DG SANTE) · Mon 26 Oct 2026

DG SANTE has revised its procedural guidance for HTA joint scientific consultations on medicines and on medical devices and in vitro diagnostics, introducing a role described as 'watcher'.

The European Commission's Directorate-General for Health and Food Safety (DG SANTE) has published updated procedural guidance for joint scientific consultations (JSCs) under the EU health technology assessment framework. The documents are dated 26 October 2026.

Two background documents are affected: one covers JSCs on medicinal products, the other JSCs on medical devices and in vitro diagnostic medical devices. According to the Commission's announcement, the update adds the role of a 'watcher'.

The material available to VigiEye does not say who may act as a watcher, what the role involves, or how it fits into the existing JSC process. It also does not set out any changes to timelines, requests or fees. Those points can only be confirmed from the full guidance texts.

As general context, joint scientific consultations allow developers to obtain advice from HTA bodies on their planned evidence generation, ahead of later assessments.

What it means for your team

  • Developers planning or running JSC requests for medicines, devices or IVDs should read both updated guidance documents to see how the watcher role affects participation.
  • Market-access and HTA-strategy teams should check whether the new role changes who attends or observes consultations, as the summary gives no detail.
  • Do not assume specific procedural consequences until confirmed in the full guidance.

Official source: European Commission (DG SANTE) ↗

Article written by VigiEye from the official source (European Commission (DG SANTE)). AI-assisted; check the source before acting.