PharmacovigilanceOfficial

SÚKL takes medical device vigilance portal offline after cybersecurity warning; EU forms to be used

🇨🇿 SÚKL · Thu 22 Oct 2026

Czech regulator SÚKL has temporarily shut its electronic vigilance reporting interface following a NÚKIB warning about a PHP vulnerability, while reporting duties remain in force.

The Czech State Institute for Drug Control (SÚKL) is temporarily taking down its electronic interface for submitting medical device vigilance reports. The notice, published on 22 October 2026, says the move is for security reasons and follows a recent warning from the national cybersecurity agency NÚKIB about a PHP vulnerability. Further details are available on the NÚKIB information portal.

SÚKL stresses that the obligation to submit vigilance reports is unaffected by the shutdown. While the interface is offline, reporters can use the official European forms published by the European Commission.

For manufacturer incident reports (MIR), SÚKL points to form MIR 7.3.1, which the Commission says has been mandatory since 1 May 2026. Field safety corrective actions (FSCAs) are to be reported on the separate FSCA form published by the Commission. An overview of current forms for post-market surveillance and vigilance (PMSV) is on the Commission's website.

The notice gives no date for restoring the electronic interface, saying only that SÚKL will inform the public when it resumes. It also does not describe how completed forms should be delivered to the authority during the outage.

What it means for your team

  • Reporting timelines continue to apply, so manufacturers and other reporters in Czechia should not treat the outage as a pause on vigilance duties.
  • Teams should have the Commission's MIR 7.3.1 and FSCA forms ready; MIR 7.3.1 has been mandatory since 1 May 2026.
  • Because the notice does not specify the delivery route for the forms or a restoration date, check SÚKL directly and watch for its update on the interface's return.
  • Quality and vigilance staff should record the outage and the submission route used for each report in their files.

Official source: SÚKL ↗

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

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