Czech SÚKL Plans Vigilance Interface Outage
On 22 October 2026, Czechia's SÚKL announced a temporary security shutdown of its electronic vigilance reporting interface following a NÚKIB PHP-vulnerability warning. Statutory reporting duties remain in force using the European Commission's MIR 7.3.1 (December 2025 SB-10781 or later, with May 2026 SB-11154 current) and FSCA forms, which SÚKL's vigilance instructions allow submitters to file as signed PDF and XML files via Data Box (qwfai2m) or email.
Regulatory Update
On 22 October 2026, the Medical Devices Regulation Section (Sekce regulace zdravotnických prostředků) of the Czech State Institute for Drug Control (Státní ústav pro kontrolu léčiv, SÚKL) published Dočasné omezení elektronického rozhraní SÚKL pro podávání vigilančních hlášení zdravotnických prostředků. Following a warning from the National Cyber and Information Security Agency (NÚKIB) regarding a serious security vulnerability in the PHP programming language, SÚKL stated that its electronic interface for submitting medical-device vigilance reports will be temporarily taken out of service for security reasons.
SÚKL emphasized that the statutory obligation to submit vigilance reports is unaffected by this measure (Povinnost podávat vigilanční hlášení není tímto opatřením dotčena). The 22 October 2026 notice uses the future tense (bude … dočasně odstaveno), does not state the exact date or hour when the shutdown begins or ends, and notes that SÚKL will inform the public once the interface is restored.
Required Forms and MIR 7.3.1 Version Rules
During the temporary outage, SÚKL directs submitters to use the official forms published by the European Commission on its Post-Market Surveillance and Vigilance (PMSV) reporting forms page:
- Serious incidents — Manufacturer Incident Report (MIR) 7.3.1: SÚKL links directly to the Commission's MIR 7.3.1 PDF form and notes that the European Commission made MIR 7.3.1 mandatory from 1 May 2026. On the Commission's PMSV forms page (under the heading MIR PDF 7.3.1 (update 7 May 2026)) and in the downloaded PDF's revision history, the Commission specifies a narrower eligibility rule:
- Acceptable MIR 7.3.1 versions until further notice: Only MIR 7.3.1 versions published from December 2025 onward remain valid — specifically December 2025 (SB-10781), March 2026 (SB-11010), April 2026 (SB-11154), and May 2026 (SB-11154) (dated 6 May 2026 in the PDF metadata to fix a bug in section 4.2.i).
- Prohibited MIR 7.3.1 versions: Versions of MIR 7.3.1 published prior to December 2025 (before SB-10781) can no longer be used.
- Field Safety Corrective Actions (FSCA): For reporting field safety corrective actions, SÚKL directs submitters to the separate European Commission FSCA report PDF form.
Alternative SÚKL Delivery Channels Outside the Web Interface
Although the 22 October 2026 notice focuses on the required Commission forms, SÚKL's published Vigilance Reporting Hub, FSCA reporting instructions, and Vigilance Form User Manual define the exact channels that apply when SÚKL's web interface (formulare-vigilance-zp.sukl.cz) is not used while EUDAMED's vigilance module is not yet mandatory under MDR Article 123(3)(d) and IVDR Article 113(3)(f):
| Submission element | SÚKL rule outside the web interface |
|---|---|
| Required file formats | Both the completed PDF form signed with a certified electronic signature and the exported XML file (plus any supporting attachments) must be submitted |
| Language | Completed electronically in Czech or English |
| Data Box (datová schránka) channel | SÚKL Data Box ID: qwfai2m |
| Electronic mail channel | posta@sukl.cz (listed in the Vigilance Form User Manual and FSCA page) or urgent@sukl.cz (also listed on SÚKL's FSCA reporting page) |
Practical Implications for Manufacturers
Pure Global analysis:
- Keep EU MDR and IVDR vigilance reporting clocks running: Because SÚKL explicitly states that statutory vigilance reporting duties are unaffected by the web-interface shutdown, manufacturers and authorized representatives managing EU MDR compliance and Czech national filings (alongside SÚKL's recent Free Sale Certificate and EUDAMED changes) must not delay initial, follow-up, or final incident reports or FSCA notifications.
- Verify that internal MIR 7.3.1 templates are December 2025 (SB-10781) or newer: Quality and post-market surveillance teams should check the revision history inside their stored MIR 7.3.1 PDF template and replace any pre-December 2025 file with the current May 2026 (SB-11154) PDF from the European Commission's PMSV page.
- Prepare dual PDF + XML packages for Data Box or email transmission: When SÚKL's web interface is unavailable, ensure vigilance SOPs include exporting the XML dataset from the Commission PDF form, applying a certified electronic signature to the PDF, and transmitting both files (together with any annexes) through SÚKL's Data Box (qwfai2m) or official email (posta@sukl.cz / urgent@sukl.cz) until SÚKL announces that the web interface is back online.
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