Market accessOfficial

Slovakia's ŠÚKL scraps deadlines for EUDAMED data matching with national device database

🇸🇰 ŠÚKL · Wed 11 Nov 2026

The Slovak medicines agency has cancelled the original dates for submitting data to match EUDAMED with its national medical device database, with further steps set out in a separate document.

The State Institute for Drug Control (ŠÚKL) in Slovakia has announced that the original deadlines for sending data used to match the EU's EUDAMED database with the national medical device database have been cancelled. The notice was published on 11 November 2026.

According to the agency, the change affects the next steps in the matching process, including how the submitted data are recorded and processed. The web notice itself does not set out the new timelines or procedures; these are described in a downloadable PDF titled "Zmena termínov na párovanie údajov" (change of deadlines for data matching).

The notice also links to ŠÚKL methodological guidance MP 152/2026, which covers the notification obligation for medical devices and changes linked to the mandatory use of EUDAMED from 28 May 2026. The page does not say how the two documents relate beyond their being listed together.

For context, EUDAMED is the European database of medical devices established under the EU Medical Device Regulation and In Vitro Diagnostic Regulation, and national authorities maintain their own registers alongside it.

What it means for your team

  • Economic operators with devices registered in Slovakia should read the ŠÚKL PDF to confirm the revised timelines, as the web notice gives no new dates.
  • Any internal plans built around the cancelled data-submission deadlines should be reviewed and updated.
  • Teams should check MP 152/2026 for the notification obligations that apply alongside mandatory EUDAMED use.

Official source: ŠÚKL ↗

Article written by VigiEye from the official source (ŠÚKL). AI-assisted; check the source before acting.

More Market access All →