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January 15, 2026
Approximately 5 minutes
Slovakia Decree No. 158/2015 Annex 6: Requirements for Clinical Evaluation and Performance Studies of IVDs
Slovakia Decree No. 158/2015 Annex 6: Requirements for Clinical Evaluation and Performance Studies of IVDs
1. Legal Basis and Purpose
Annex 6 (Príloha č. 6) to Decree of the Ministry of Health No. 158/2015 Z.z. details the obligations for clinical evaluation and performance assessment of in vitro diagnostic medical devices (IVDs) under the Slovak transposition of Directive 98/79/EC. It specifies the data and evidence manufacturers must generate and maintain to demonstrate scientific validity, analytical performance and clinical performance. The annex remains applicable for legacy IVDs during the IVDR transitional period (Regulation (EU) 2017/746 Article 110). Source: Decree No. 158/2015 Z.z. Annex 6 (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2015/158/20151215#prilohy.priloha-priloha_c_6_k_vyhlaske_c_158_2015_z_z.oznacenie)
2. Scope of Application
This annex applies to:
- All IVDs placed on the Slovak market (self-declared and higher classes)
- Devices requiring performance evaluation reports (PER)
- Legacy IVDs under Directive 98/79/EC during transition
- IVDs undergoing performance studies in Slovakia
It covers both quantitative and qualitative IVDs, including companion diagnostics and near-patient testing devices. Source: Decree No. 158/2015 Z.z. Annex 6 introductory provisions (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2015/158/20151215#prilohy.priloha-priloha_c_6_k_vyhlaske_c_158_2015_z_z.oznacenie)
3. Core Elements of Performance Evaluation
Manufacturers must demonstrate:
- Scientific validity: Established association between analyte and clinical condition
- Analytical performance: Accuracy, precision, sensitivity, specificity, LoB, LoD, LoQ, linearity, etc.
- Clinical performance: Diagnostic sensitivity/specificity, PPV/NPV, likelihood ratios, clinical utility evidence
Evidence must come from:
- Published literature
- Own performance studies
- Equivalence to predicate devices
- Combination of the above
Source: Decree No. 158/2015 Z.z. Annex 6 main requirements (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2015/158/20151215#prilohy.priloha-priloha_c_6_k_vyhlaske_c_158_2015_z_z.oznacenie)
4. Performance Study Requirements
Performance studies must:
- Be planned according to a protocol with predefined objectives and endpoints
- Use appropriate reference methods or clinical outcomes
- Include sufficient number of samples and statistical justification
- Be conducted under conditions resembling routine use
- Be documented in a performance study report
For higher-risk IVDs, studies may require ethics committee approval and notification to authorities. Source: Decree No. 158/2015 Z.z. Annex 6 performance study section (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2015/158/20151215#prilohy.priloha-priloha_c_6_k_vyhlaske_c_158_2015_z_z.oznacenie)
5. Documentation and Technical File Integration
The performance evaluation report (PER) must be included in the technical documentation and updated throughout the device lifecycle. It should contain:
- Summary of scientific validity
- Analytical performance data
- Clinical performance evidence
- Post-market surveillance plan linkage
- Benefit-risk analysis specific to IVD
Source: Decree No. 158/2015 Z.z. Annex 6 documentation obligations (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2015/158/20151215#prilohy.priloha-priloha_c_6_k_vyhlaske_c_158_2015_z_z.oznacenie)
6. Transitional Considerations under IVDR
For legacy IVDs under IVDR transitional provisions:
- Continue to follow Annex 6 requirements until certificate expiry or full IVDR application
- Update performance evaluation to meet IVDR Annex XIII level of evidence
- Prepare for EUDAMED registration and vigilance reporting changes
Source: Decree No. 158/2015 Z.z. Annex 6 (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2015/158/20151215#prilohy.priloha-priloha_c_6_k_vyhlaske_c_158_2015_z_z.oznacenie)
7. Practical Guidance for RA Managers
- Map intended use to appropriate performance characteristics
- Conduct gap analysis against Annex 6 requirements
- Use literature reviews to support scientific validity
- Plan performance studies with statistical power calculation
- Maintain version-controlled PER with change history
- Prepare for IVDR level of evidence increase (especially Class C/D)
Source: Decree No. 158/2015 Z.z. Annex 6 (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2015/158/20151215#prilohy.priloha-priloha_c_6_k_vyhlaske_c_158_2015_z_z.oznacenie)
8. Common Compliance Challenges
- Insufficient clinical performance data for rare analytes
- Poorly justified equivalence claims
- Outdated analytical performance data
- Lack of linkage between analytical and clinical performance
- Inadequate post-market surveillance planning
Source: Decree No. 158/2015 Z.z. Annex 6 practical application notes (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2015/158/20151215#prilohy.priloha-priloha_c_6_k_vyhlaske_c_158_2015_z_z.oznacenie)
9. Alignment with IVDR Performance Evaluation
While Annex 6 transposes Directive 98/79/EC, full IVDR application requires:
- Higher evidence standards (Annex XIII)
- Continuous update of PER
- Post-market performance follow-up plan
- EUDAMED vigilance integration
Manufacturers should align legacy documentation with IVDR expectations. Source: Decree No. 158/2015 Z.z. Annex 6 (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2015/158/20151215#prilohy.priloha-priloha_c_6_k_vyhlaske_c_158_2015_z_z.oznacenie)
10. RA Checklist for IVD Performance Evaluation
- Scientific validity evidence documented?
- Analytical performance parameters fully validated?
- Clinical performance supported by adequate studies?
- PER updated with latest PMS data?
- Equivalence justification robust if used?
- Slovak labelling reflects performance claims?
- Ready for IVDR re-assessment?
Source: Decree No. 158/2015 Z.z. Annex 6 (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2015/158/20151215#prilohy.priloha-priloha_c_6_k_vyhlaske_c_158_2015_z_z.oznacenie)
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