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January 15, 2026
Approximately 5 minutes
Slovakia Decree No. 158/2015 Annex 10: Post-Market Surveillance and Vigilance Reporting Obligations for Medical Devices
Slovakia Decree No. 158/2015 Annex 10: Post-Market Surveillance and Vigilance Reporting Obligations for Medical Devices
1. Legal Basis and Applicability
Annex 10 (Príloha č. 10) to Decree No. 158/2015 Z.z. specifies the post-market surveillance (PMS) and vigilance obligations for all classes of medical devices placed on the Slovak market. It transposes the requirements of Directive 93/42/EEC (MDD) Annex II, III, V and VI, and remains applicable to legacy devices during the MDR transitional period (Regulation (EU) 2017/745 Article 120). Source: Decree No. 158/2015 Z.z. Annex 10 (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2015/158/20151215#prilohy.priloha-priloha_c_10_k_vyhlaske_c_158_2015_z_z.oznacenie)
2. Scope of Devices Covered
This annex applies to:
- All medical devices (Class I to III, including custom-made and sterile Class I)
- Devices incorporating medicinal substances or biological tissues
- Active implantable devices
- Manufacturers, authorised representatives, importers and distributors with obligations
Source: Decree No. 158/2015 Z.z. Annex 10 introductory scope (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2015/158/20151215#prilohy.priloha-priloha_c_10_k_vyhlaske_c_158_2015_z_z.oznacenie)
3. Post-Market Surveillance (PMS) Requirements
Manufacturers must establish and maintain a PMS system including:
- Proactive collection of data on device performance, safety and risk-benefit
- Trend analysis of non-serious incidents and complaints
- Periodic safety update reports (PSUR) for higher-risk devices
- Update of risk management file and clinical evaluation based on PMS data
PMS data must feed into CAPA processes and design improvements. Source: Decree No. 158/2015 Z.z. Annex 10 PMS section (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2015/158/20151215#prilohy.priloha-priloha_c_10_k_vyhlaske_c_158_2015_z_z.oznacenie)
4. Vigilance Reporting Obligations
- Serious incidents must be reported to ŠÚKL immediately (within deadlines transposed from MDD)
- Field safety corrective actions (FSCA) require prior notification to ŠÚKL
- Field safety notices (FSN) must be issued in Slovak to affected users
- Trend reporting for non-serious incidents that could become serious
Source: Decree No. 158/2015 Z.z. Annex 10 vigilance provisions (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2015/158/20151215#prilohy.priloha-priloha_c_10_k_vyhlaske_c_158_2015_z_z.oznacenie)
5. Periodic Safety Update Reports (PSUR)
For Class IIb and III devices (and certain IIa):
- Submit PSUR to ŠÚKL at defined intervals (typically annual or biennial)
- Include summary of PMS data, risk-benefit analysis, FSCA status, trend conclusions
- PSUR must be updated throughout device lifecycle
Source: Decree No. 158/2015 Z.z. Annex 10 PSUR requirements (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2015/158/20151215#prilohy.priloha-priloha_c_10_k_vyhlaske_c_158_2015_z_z.oznacenie)
6. Field Safety Corrective Actions (FSCA) and FSN
- FSCA (recall, field update, modification) requires ŠÚKL notification before implementation
- FSN must be in Slovak, clear and actionable
- Effectiveness checks and reconciliation reports submitted to ŠÚKL
- Coordination with EU authorities via vigilance network
Source: Decree No. 158/2015 Z.z. Annex 10 FSCA/FSN section (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2015/158/20151215#prilohy.priloha-priloha_c_10_k_vyhlaske_c_158_2015_z_z.oznacenie)
7. MDR Transition Implications
Legacy devices follow Annex 10 vigilance until MDD certificate expiry. Full MDR introduces:
- Stricter PMS plan per Annex III
- Periodic safety update reports for all classes
- Mandatory EUDAMED vigilance module
- Enhanced trend and serious incident reporting
Source: Decree No. 158/2015 Z.z. Annex 10 (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2015/158/20151215#prilohy.priloha-priloha_c_10_k_vyhlaske_c_158_2015_z_z.oznacenie)
8. Practical RA Checklist
- Maintain active PMS plan with data sources and analysis methods
- Set up internal vigilance escalation and reporting SOP
- Prepare Slovak FSN templates and distribution lists
- Schedule PSUR submission calendar for higher-risk devices
- Conduct regular trend reviews and document conclusions
- Train staff on serious incident criteria and deadlines
- Integrate PMS data into risk management updates
Source: Decree No. 158/2015 Z.z. Annex 10 (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2015/158/20151215#prilohy.priloha-priloha_c_10_k_vyhlaske_c_158_2015_z_z.oznacenie)
9. Common Compliance Challenges
- Inadequate trend analysis leading to missed signals
- Delayed or incomplete serious incident reporting
- Missing PSUR for Class IIb/III devices
- Poor documentation of FSCA effectiveness
- Language barriers in FSN distribution
Source: Decree No. 158/2015 Z.z. Annex 10 practical notes (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2015/158/20151215#prilohy.priloha-priloha_c_10_k_vyhlaske_c_158_2015_z_z.oznacenie)
10. ŠÚKL Role and Enforcement
ŠÚKL receives vigilance reports, assesses trends, coordinates FSCA, and may impose corrective measures or sanctions for non-compliance. Higher-risk devices receive enhanced surveillance. Source: Decree No. 158/2015 Z.z. Annex 10 (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2015/158/20151215#prilohy.priloha-priloha_c_10_k_vyhlaske_c_158_2015_z_z.oznacenie)
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