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January 30, 2026
Approximately 5 minutes
Slovakia Act No. 362/2011 §141(1)(b): Immediate Reporting Duty for Serious Incidents and FSCA
Slovakia Act No. 362/2011 §141(1)(b): Immediate Reporting Duty for Serious Incidents and FSCA
1. Provision Text and Core Obligation
Section 141(1)(b) requires that every manufacturer, authorised representative established in Slovakia, importer or distributor who becomes aware of a serious incident or field safety corrective action concerning a medical device placed on the market shall immediately inform the State Institute for Drug Control (ŠÚKL). This obligation transposes MDD Article 10 vigilance requirements. Source: Act No. 362/2011 Coll. §141(1)(b) (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-141.odsek-1.pismeno-b)
2. Who Has the Reporting Duty
- Manufacturers (regardless of location if device is on Slovak market)
- Authorised representatives with registered office in Slovakia
- Importers placing devices on the Slovak market
- Distributors who become aware of serious incidents with devices they have supplied
Healthcare institutions and users are encouraged but not legally obligated under this provision to report directly. Source: Act No. 362/2011 Coll. §141(1)(b) (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-141.odsek-1.pismeno-b)
3. Definition of Serious Incident (Cross-Reference)
Serious incident means any malfunction, deterioration in characteristics/performance, inadequacy of labelling/instructions or other issue that:
- led to or might have led to death or serious deterioration in health
- required or might have required medical/surgical intervention to prevent permanent impairment
Exclusions apply for incidents solely due to patient condition or user error with documented rationale. Source: Act No. 362/2011 Coll. §141(1)(b) referencing MDD Art. 2 (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-141.odsek-1.pismeno-b)
4. What Constitutes Field Safety Corrective Action (FSCA)
FSCA includes any action to reduce risk of serious incidents with devices already placed on the market, such as:
- Device recall
- Field safety notice with instructions
- Software/field modification
- Device return or destruction
Any FSCA requires immediate ŠÚKL notification before implementation. Source: Act No. 362/2011 Coll. §141(1)(b) (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-141.odsek-1.pismeno-b)
5. Reporting Timeline and Process
- "Immediately" means without undue delay upon becoming aware
- Initial report followed by follow-up with root cause, CAPA plan and trend data
- Reports submitted electronically via ŠÚKL vigilance portal
- Distributor-specific 2-working-day initial report deadline in some cases
Source: Act No. 362/2011 Coll. §141(1)(b) (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-141.odsek-1.pismeno-b)
6. ŠÚKL Role Upon Receipt
ŠÚKL:
- Registers and assesses the report
- May request additional information or corrective measures
- Coordinates national response and FSCA implementation
- Collaborates with other EU competent authorities
- May order urgent measures (e.g., supply suspension, recall)
Source: Act No. 362/2011 Coll. §141(1)(b) (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-141.odsek-1.pismeno-b)
7. MDR Transition Application
Legacy devices under MDD certificates follow §141(1)(b) vigilance until expiry. New devices comply with MDR Articles 87–89 (10/2/1-day timelines, EUDAMED submission). Manufacturers should align processes progressively. Source: Act No. 362/2011 Coll. §141(1)(b) (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-141.odsek-1.pismeno-b)
8. RA Manager Practical Guidance
- Implement 24/7 serious incident awareness and escalation protocol
- Train staff on serious incident criteria vs. reportable events
- Maintain central vigilance log with ŠÚKL submission proofs
- Prepare Slovak-language FSN templates in advance
- Document all ŠÚKL interactions and follow-up commitments
- Integrate global vigilance with Slovak-specific obligations
Source: Act No. 362/2011 Coll. §141(1)(b) (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-141.odsek-1.pismeno-b)
9. Non-Compliance Risks
Failure to report may trigger:
- Administrative penalties
- Product withdrawal/recall orders
- Marketing authorisation suspension/revocation
- Civil/criminal liability if harm occurs
Source: Act No. 362/2011 Coll. enforcement provisions (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-141.odsek-1.pismeno-b)
10. Alignment with Full MDR Vigilance
§141(1)(b) implements MDD vigilance; MDR introduces:
- Fixed timelines (10 days serious, 2 days death/serious deterioration, 1 day public health threat)
- Mandatory EUDAMED submission
- Periodic summary reporting
- Enhanced trend reporting
Harmonise Slovak obligations with MDR requirements. Source: Act No. 362/2011 Coll. §141(1)(b) (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-141.odsek-1.pismeno-b)
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