Czech Republic Decree No. 171/2021: Detailed Requirements for Medical Device Vigilance and Market Surveillance

1. Purpose and Legal Basis

Government Decree No. 171/2021 Coll. (effective from 26 April 2021) implements specific national provisions under Act No. 378/2007 Coll. on Pharmaceuticals (as amended) and supplements the directly applicable Regulation (EU) 2017/745 (MDR) concerning vigilance and market surveillance of medical devices. It details procedures for reporting serious incidents, field safety corrective actions, trend reporting, and periodic summary reports to the State Institute for Drug Control (SÚKL). Source: Decree No. 171/2021 Sb. (https://mzd.gov.cz/wp-content/uploads/2021/05/Vyhl%C3%A1%C5%A1ka-%C4%8D.-171_2021-Sb..pdf)

2. Scope of Application

Applies to all medical devices placed on the Czech market, including custom-made devices, systems/procedure packs, and devices with ancillary medicinal substances. Excludes in vitro diagnostic medical devices (covered separately). Covers manufacturers, authorised representatives, importers, distributors, and healthcare providers using devices. Source: Decree No. 171/2021 Sb. (https://mzd.gov.cz/wp-content/uploads/2021/05/Vyhl%C3%A1%C5%A1ka-%C4%8D.-171_2021-Sb..pdf)

3. Definitions of Serious Incidents and Reportable Events

• Serious incident: Any incident that led to death, serious deterioration in health, or required medical intervention to prevent permanent impairment.
• Field safety corrective action (FSCA): Action to reduce risk of serious incidents with devices already on the market (e.g., recall, modification, software update).
• Trend reporting: Required when non-serious incidents or expected side effects increase unexpectedly in frequency/severity.

Source: Decree No. 171/2021 Sb. (https://mzd.gov.cz/wp-content/uploads/2021/05/Vyhl%C3%A1%C5%A1ka-%C4%8D.-171_2021-Sb..pdf)

4. Reporting Timelines and Procedures

• Serious incidents: Immediate report to SÚKL (within 10 days for Class I; 2 days for death/permanent impairment).
• FSCA: Manufacturer notifies SÚKL before action; field safety notice (FSN) in Czech language.
• Trend reports: Within 30 days of identification.
• Periodic summary reports: Frequency agreed with SÚKL (at least annually for high-risk devices).
• Reports submitted electronically via SÚKL portal.

Source: Decree No. 171/2021 Sb. (https://mzd.gov.cz/wp-content/uploads/2021/05/Vyhl%C3%A1%C5%A1ka-%C4%8D.-171_2021-Sb..pdf)

5. Content Requirements for Reports

• Manufacturer report: Device identification (UDI if available), description of incident, root cause analysis (if known), risk assessment, corrective actions.
• User/healthcare provider report: Patient outcome, device details, circumstances of incident.
• FSCA/FSN: Clear instructions for users, risk mitigation, replacement/repair details.

Source: Decree No. 171/2021 Sb. (https://mzd.gov.cz/wp-content/uploads/2021/05/Vyhl%C3%A1%C5%A1ka-%C4%8D.-171_2021-Sb..pdf)

6. SÚKL Coordination and Actions

• SÚKL evaluates reports, may request additional information or corrective measures.
• Coordinates with EU competent authorities via EUDAMED (when operational).
• Can order suspension of supply, recall, or other market restrictions.
• Maintains national vigilance database linked to EUDAMED.

Source: Decree No. 171/2021 Sb. (https://mzd.gov.cz/wp-content/uploads/2021/05/Vyhl%C3%A1%C5%A1ka-%C4%8D.-171_2021-Sb..pdf)

7. Obligations of Other Economic Operators

• Authorised representatives: Forward vigilance reports from manufacturer to SÚKL.
• Importers/distributors: Report incidents they become aware of; cooperate in FSCA.
• Healthcare providers: Mandatory reporting of serious incidents within 2 working days.

Source: Decree No. 171/2021 Sb. (https://mzd.gov.cz/wp-content/uploads/2021/05/Vyhl%C3%A1%C5%A1ka-%C4%8D.-171_2021-Sb..pdf)

8. Language and Communication

• Reports to SÚKL can be in Czech, English, or Slovak.
• Field safety notices and user communications must be in Czech.
• SÚKL may require translation of technical documentation in enforcement cases.

Source: Decree No. 171/2021 Sb. (https://mzd.gov.cz/wp-content/uploads/2021/05/Vyhl%C3%A1%C5%A1ka-%C4%8D.-171_2021-Sb..pdf)

9. Transitional and Implementation Notes

• Applies to all devices under MDR scope from May 2021.
• Legacy devices under Directive 93/42/EEC follow transitional vigilance rules.
• SÚKL provides electronic reporting forms and guidance on its website.

Source: Decree No. 171/2021 Sb. (https://mzd.gov.cz/wp-content/uploads/2021/05/Vyhl%C3%A1%C5%A1ka-%C4%8D.-171_2021-Sb..pdf)

10. Practical Guidance for RA Managers

Establish direct electronic reporting channel to SÚKL. Train staff on Czech-specific timelines (shorter for death/permanent impairment). Prepare Czech-language FSN templates. Maintain robust trend monitoring to avoid late reporting. Use SÚKL portal for submissions and track status. Coordinate vigilance with EU EUDAMED obligations. Source: Decree No. 171/2021 Sb. (https://mzd.gov.cz/wp-content/uploads/2021/05/Vyhl%C3%A1%C5%A1ka-%C4%8D.-171_2021-Sb..pdf)