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February 20, 2026
Approximately 5 minutes
Slovakia Act No. 362/2011 §141(1)(b): Mandatory Serious Incident Reporting for Medical Devices
Slovakia Act No. 362/2011 §141(1)(b): Mandatory Serious Incident Reporting for Medical Devices
1. Legal Provision Overview
Paragraph 141(1)(b) of Act No. 362/2011 Coll. on Medicinal Products and Medical Devices (as amended) requires economic operators (manufacturers, authorised representatives established in Slovakia, importers, distributors) to immediately report to ŠÚKL any serious incident or field safety corrective action (FSCA) concerning a medical device they have placed on the market. This provision transposes the vigilance obligations of Directive 93/42/EEC (MDD) Article 10 and Annex II and continues to apply to legacy devices during the MDR transitional period (Regulation (EU) 2017/745 Article 120). 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. Definition of Serious Incident
A serious incident is defined as any malfunction, deterioration in characteristics or performance, or inadequacy in labelling/instructions that:
- Led to or could have led to death or serious deterioration in health of a patient, user or other person
- Required or could have required medical or surgical intervention to prevent permanent impairment
Incidents solely due to patient pre-existing condition or user error may be excluded after documented rationale. Source: Act No. 362/2011 Coll. §141(1)(b) cross-referencing MDD Art. 2 & MDR Art. 2(65) (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-141.odsek-1.pismeno-b)
3. Who Must Report and Deadlines
- Manufacturers / Authorised Representatives: Report without undue delay (immediately) upon awareness
- Importers / Distributors: Report within 2 working days if they become aware of a serious incident with a device they placed on the market
- Initial report followed by follow-up reports with root cause analysis, corrective actions and trend data
Healthcare professionals and users are encouraged to report to the manufacturer and/or ŠÚKL. 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)
4. Required Report Content
The vigilance report to ŠÚKL must include at minimum:
- Device identification (name, model, UDI, serial/lot/batch)
- Incident description (date, circumstances, patient outcome)
- Preliminary risk assessment and suspected cause
- Actions taken or planned (investigation, FSCA, FSN)
- Reporter contact details
Reports submitted electronically via ŠÚKL vigilance portal. Source: Act No. 362/2011 Coll. §141(1)(b) & ŠÚKL guidance (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-141.odsek-1.pismeno-b)
5. Field Safety Corrective Actions (FSCA) and FSN
When an FSCA is required (recall, software/field update, modification):
- Notify ŠÚKL in advance
- Prepare and distribute Field Safety Notice (FSN) in Slovak to affected users
- Provide ŠÚKL with proof of dissemination and effectiveness
ŠÚKL may coordinate with other EU authorities via EUDAMED (when operational). Source: Act No. 362/2011 Coll. §141(1)(b) in context of MDR Art. 89 (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-141.odsek-1.pismeno-b)
6. ŠÚKL Role and National Coordination
ŠÚKL:
- Receives, assesses and registers vigilance reports
- Requests additional information or corrective measures
- Coordinates national response and communicates with the economic operator
- May order urgent measures (supply suspension, recall, etc.)
- Uploads data to EUDAMED and collaborates with other EU competent authorities
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. Transitional Period under MDR
Legacy devices under MDD transitional provisions follow the vigilance requirements transposed in §141(1)(b). New devices comply directly with MDR vigilance rules (Articles 87–89). Manufacturers should prepare for full MDR alignment, including EUDAMED reporting. 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. Practical Guidance for RA Managers
- Establish internal vigilance SOP with clear 24/7 escalation path
- Train staff on serious incident thresholds (death/permanent impairment = immediate)
- Use ŠÚKL electronic portal for submissions and maintain audit trail
- Prepare Slovak-language FSN templates in advance
- Document all ŠÚKL communications and follow-up actions
- Coordinate global vigilance reporting 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. Consequences of Non-Compliance
Failure to report under §141(1)(b) may result in:
- Administrative fines
- Product withdrawal or recall orders
- Suspension/revocation of marketing authorisation
- Potential criminal sanctions in cases causing serious harm
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
While §141(1)(b) implements MDD vigilance, full MDR application introduces:
- Stricter initial reporting timelines (10/2/1 days)
- Periodic summary reporting for certain devices
- Mandatory EUDAMED submission
- Enhanced trend reporting obligations
Manufacturers should harmonise Slovak requirements with MDR to avoid duplication. 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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