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January 20, 2026
Approximately 5 minutes
Slovakia Act No. 362/2011 §46(5): Authorized Representative Notification of Serious Incidents
Slovakia Act No. 362/2011 §46(5): Authorized Representative Notification of Serious Incidents
1. Legal Provision Text
Paragraph 46(5) states that the authorized representative shall immediately notify the competent authority of any serious incident or field safety corrective action involving a medical device for which he acts as the authorized representative, in accordance with the special regulation on vigilance. Source: Act No. 362/2011 Coll. §46(5) (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-46.odsek-5)
2. Scope of Notification Obligation
The AR must report:
- Serious incidents (death, serious deterioration in health, serious public health threat)
- Field safety corrective actions (FSCA) initiated by the manufacturer
- Any corrective or preventive action taken in response to incidents
- Incidents occurring with devices placed on the Slovak market by non-EU manufacturers
Notification is immediate and follows vigilance procedures. Source: Act No. 362/2011 Coll. §46(5) (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-46.odsek-5)
3. Reporting Timeline and Process
- Immediate notification upon becoming aware of the incident
- Use ŠÚKL vigilance reporting forms/system
- Provide initial report within required timeframe (typically 10 days for serious incidents)
- Follow-up reports as new information becomes available
- Coordinate with manufacturer for joint reporting where possible
Source: Act No. 362/2011 Coll. §46(5) (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-46.odsek-5)
4. MDR Transition Application
For legacy devices under MDD transitional provisions (MDR Article 120):
- §46(5) vigilance notification continues until MDD certificate expiry
- After transition, MDR Article 11(5) and Article 87 impose enhanced vigilance obligations on ARs
- ARs must prepare for stricter MDR reporting timelines and EUDAMED integration
Source: Act No. 362/2011 Coll. §46(5) (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-46.odsek-5)
5. Practical RA Guidance for ARs
- Establish 24/7 incident awareness and escalation protocol
- Maintain direct communication channel with manufacturer vigilance team
- Train local staff on serious incident criteria and reporting
- Keep audit trail of all ŠÚKL notifications and follow-ups
- Integrate vigilance reporting into QMS for traceability
- Prepare template for initial and follow-up reports
Source: Act No. 362/2011 Coll. §46(5) (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-46.odsek-5)
6. Common Vigilance Reporting Challenges
- Delays in receiving incident details from manufacturer
- Uncertainty on serious incident classification
- Language barriers in reporting to ŠÚKL
- Coordination issues during FSCA implementation
- Incomplete manufacturer root cause analysis
Source: Act No. 362/2011 Coll. §46(5) practical notes (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-46.odsek-5)
7. RA Vigilance Checklist for ARs
- Is there a 24/7 contact for incident alerts?
- Are serious incident criteria clearly documented?
- Is ŠÚKL reporting form/template ready?
- Is manufacturer-AR vigilance agreement in place?
- Are past reports logged and reviewed?
- Is escalation protocol tested annually?
Source: Act No. 362/2011 Coll. §46(5) (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-46.odsek-5)
8. Enforcement and Non-Compliance Risks
Failure to notify may lead to:
- Administrative fines
- Order to cease distribution
- Potential criminal sanctions in severe cases
- Reputational damage and loss of authorization
Source: Act No. 362/2011 Coll. enforcement provisions (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-46.odsek-5)
9. Alignment with MDR Vigilance Requirements
While §46(5) aligns with MDD vigilance, MDR Articles 87–89 introduce:
- Stricter timelines (e.g., 15/10/2 days depending on severity)
- Mandatory EUDAMED reporting
- Trend reporting obligations
- Periodic safety update reports (PSUR) for certain devices
ARs should enhance vigilance processes for MDR readiness. Source: Act No. 362/2011 Coll. §46(5) (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-46.odsek-5)
10. Best Practices for Effective Vigilance
- Conduct regular vigilance training and simulations
- Use secure digital platform for manufacturer-AR communication
- Maintain bilingual vigilance documentation
- Review all ŠÚKL feedback on reports
- Participate in EU vigilance networks for harmonization
Source: Act No. 362/2011 Coll. §46(5) (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-46.odsek-5)
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