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January 10, 2026
Approximately 5 minutes
Slovakia Act No. 362/2011 §141(1)(b): Vigilance Reporting Obligations for Serious Incidents
Slovakia Act No. 362/2011 §141(1)(b): Vigilance Reporting Obligations for Serious Incidents
1. Legal Provision and Scope
Paragraph 141(1)(b) of Act No. 362/2011 Coll. on Medicinal Products and Medical Devices (as amended) imposes a mandatory vigilance reporting obligation on all economic operators involved in the supply chain of medical devices. This provision implements the national framework for post-market surveillance and serious incident reporting, historically aligned with Directive 93/42/EEC Annex II and now harmonised with Regulation (EU) 2017/745 (MDR) Articles 87–89 during the transitional period. The obligation applies to manufacturers, authorised representatives established in Slovakia, importers and distributors. 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 Reportable Serious Incidents
A serious incident must be reported if it:
- Led to the death of a patient, user or other person
- Led to the temporary or permanent serious deterioration in health of a patient, user or other person
- Required medical or surgical intervention to prevent permanent impairment of a body structure or function
Incidents that are clearly attributable to the patient's pre-existing condition or user error may be excluded after documented justification. Source: Act No. 362/2011 Coll. §141(1)(b) cross-referenced with 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 Timelines
- Manufacturers / Authorised Representatives: Immediate reporting (without undue delay) upon becoming aware of the incident.
- Importers / Distributors: Report within 2 working days if they become aware of a serious incident involving a device they placed on the market.
- Healthcare providers / Users: Encouraged (and in some cases required under professional obligations) to report to the manufacturer and/or ŠÚKL.
Initial report must be submitted as soon as possible, followed by follow-up reports with root cause analysis and corrective actions. 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 Content of the Report
The vigilance report to ŠÚKL must include at minimum:
- Device identification (name, model, UDI if available, serial/lot number)
- Description of the incident (date, circumstances, patient outcome)
- Preliminary risk assessment
- Actions already taken or proposed (investigation, field safety corrective action, etc.)
- Contact details of the reporting entity
Reports are submitted electronically via the ŠÚKL vigilance portal. Source: Act No. 362/2011 Coll. §141(1)(b) & implementing 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 a FSCA is required (e.g., recall, software update, modification), the manufacturer must:
- Notify ŠÚKL prior to implementation
- Prepare and distribute a Field Safety Notice (FSN) in Slovak language
- Provide ŠÚKL with evidence of dissemination to affected users
ŠÚKL may coordinate with other EU authorities via EUDAMED (when fully 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 Coordination
The State Institute for Drug Control (ŠÚKL):
- Receives and evaluates vigilance reports
- May request additional information or corrective measures
- Coordinates national response and communicates with manufacturers
- Uploads relevant data to EUDAMED and collaborates with other EU competent authorities
ŠÚKL can issue orders for urgent measures including supply suspension or 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. Transitional Application under MDR
During the MDR transitional period (per Article 120), legacy devices follow the vigilance requirements of the MDD as transposed in §141(1)(b), while new devices comply directly with MDR vigilance rules. Manufacturers should prepare for full MDR alignment, including use of EUDAMED for 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 a robust internal vigilance system with clear escalation paths.
- Train staff on immediate reporting thresholds (death/permanent impairment = urgent).
- Use ŠÚKL electronic portal for submissions and maintain audit trail.
- Prepare Slovak-language FSN templates in advance.
- Document all communications with ŠÚKL and follow-up actions.
- Coordinate global vigilance with local Slovak 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)
9. Consequences of Non-Reporting
Failure to comply with §141(1)(b) reporting obligations may result in:
- Administrative fines
- Product withdrawal orders
- Suspension of marketing authorisation
- Potential criminal sanctions in cases of 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 EU MDR Vigilance
While §141(1)(b) historically implemented MDD vigilance, full MDR application requires:
- Reporting via EUDAMED
- Stricter timelines (e.g., 10/2/1 day initial reports)
- Periodic summary reports for certain devices
Manufacturers should align Slovak obligations with MDR requirements to avoid dual 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)
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