January 5, 2026
Approximately 5 minutes
Reviewed by Nate Lam, Founder & Director, ElendiLabs
Slovakia Decree No. 158/2015 Annex 3 Part B: Documentation Obligations for Class IIa/IIb/III Devices
1. Legal Basis and Applicability
Part B of Annex 3 (Príloha č. 3 – časť B) to Decree No. 158/2015 Z.z. specifies the documentation requirements for Class IIa, IIb and III medical devices (and certain Class I requiring notified body involvement) when notifying or registering with the State Institute for Drug Control (ŠÚKL). It transposes the higher-risk obligations from Directive 93/42/EEC (MDD) Annexes II, III, V and VI and applies to legacy devices during the MDR transitional period (Regulation (EU) 2017/745 Article 120). Source: Decree No. 158/2015 Z.z. Annex 3 Part B (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2015/158/20151215#prilohy.priloha-priloha_c_3_k_vyhlaske_c_158_2015_z_z.op-skupinaElementov_poziadavky_na_informacie.op-cast_b)
2. Devices Covered
This part covers:
- All Class IIa, IIb and III devices
- Class I devices that are sterile, measuring or reusable surgical instruments requiring conformity assessment
- Devices incorporating medicinal substances, human/animal tissues or derivatives
- Active implantable devices (if applicable under national rules)
Self-declared non-sterile/non-measuring Class I devices are handled under Part A. Source: Decree No. 158/2015 Z.z. Annex 3 Part B scope (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2015/158/20151215#prilohy.priloha-priloha_c_3_k_vyhlaske_c_158_2015_z_z.op-skupinaElementov_poziadavky_na_informacie.op-cast_b)
3. Key Documentation Elements
The submission to ŠÚKL must include:
- Manufacturer and authorised representative identification
- Device nomenclature (GMDN/UDI where available), models, intended purpose
- Signed Declaration of Conformity
- Full notified body certificate(s) or certified copies
- Technical documentation summary (design dossier excerpts, essential requirements checklist)
- Risk management file summary (ISO 14971 compliant)
- Labelling, instructions for use and promotional materials in Slovak
- Vigilance history summary and any ongoing FSCA/FSN
- Periodic safety update report or PMS data excerpt
Source: Decree No. 158/2015 Z.z. Annex 3 Part B core requirements (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2015/158/20151215#prilohy.priloha-priloha_c_3_k_vyhlaske_c_158_2015_z_z.op-skupinaElementov_poziadavky_na_informacie.op-cast_b)
4. Special Documentation for Specific Device Types
- Medicinal substance combination → Pharmaceutical dossier excerpts and interaction data
- Biological tissue/animal origin → Origin, processing, viral safety, TSE/BSE risk assessment
- Active implantable → AIMD-specific technical summary
- Software → Software lifecycle documentation, validation and cybersecurity measures
Source: Decree No. 158/2015 Z.z. Annex 3 Part B special provisions (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2015/158/20151215#prilohy.priloha-priloha_c_3_k_vyhlaske_c_158_2015_z_z.op-skupinaElementov_poziadavky_na_informacie.op-cast_b)
5. Language and Submission Format
- Primary submission language: Slovak (certified translations mandatory for non-Slovak originals)
- Technical sections: English permitted with Slovak summaries for critical safety/performance aspects
- Electronic submission preferred via ŠÚKL portal; paper only if specifically requested
Source: Decree No. 158/2015 Z.z. Annex 3 Part B format rules (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2015/158/20151215#prilohy.priloha-priloha_c_3_k_vyhlaske_c_158_2015_z_z.op-skupinaElementov_poziadavky_na_informacie.op-cast_b)
6. Changes Requiring Updated Submission
Significant modifications (design, intended use, risk profile) necessitate full or partial re-submission. Minor administrative changes require notification only. Source: Decree No. 158/2015 Z.z. Annex 3 Part B change provisions (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2015/158/20151215#prilohy.priloha-priloha_c_3_k_vyhlaske_c_158_2015_z_z.op-skupinaElementov_poziadavky_na_informacie.op-cast_b)
7. MDR Transition Implications
Legacy higher-risk devices maintain compliance with Annex 3 Part B until MDD certificate expiry. New devices follow MDR Annex II/III documentation and EUDAMED registration. Manufacturers should plan progressive alignment. Source: Decree No. 158/2015 Z.z. Annex 3 Part B (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2015/158/20151215#prilohy.priloha-priloha_c_3_k_vyhlaske_c_158_2015_z_z.op-skupinaElementov_poziadavky_na_informacie.op-cast_b)
8. RA Manager Practical Checklist
- Verify notified body certificate validity and scope
- Prepare complete Slovak labelling/IFU package
- Include ISO 14971 risk management summary
- Attach vigilance/PSUR excerpts for established devices
- Document biological/medicinal assessments if applicable
- Submit via ŠÚKL portal and archive confirmation
- Track certificate expiry for MDR planning
Source: Decree No. 158/2015 Z.z. Annex 3 Part B (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2015/158/20151215#prilohy.priloha-priloha_c_3_k_vyhlaske_c_158_2015_z_z.op-skupinaElementov_poziadavky_na_informacie.op-cast_b)
9. Frequent Submission Deficiencies
- Incomplete or outdated notified body certificate
- Missing Slovak translations of key safety sections
- Inadequate risk management summary
- Lack of vigilance history for marketed devices
- Weak justification for special material safety
Source: Decree No. 158/2015 Z.z. Annex 3 Part B practical notes (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2015/158/20151215#prilohy.priloha-priloha_c_3_k_vyhlaske_c_158_2015_z_z.op-skupinaElementov_poziadavky_na_informacie.op-cast_b)
10. ŠÚKL Review Timeline and Outcomes
ŠÚKL assesses completeness and basic compliance within 30–90 days (complexity-dependent). Acceptance leads to registration confirmation; deficiencies trigger clarification requests or refusal. Higher-risk devices often receive enhanced market surveillance. Source: Decree No. 158/2015 Z.z. Annex 3 Part B procedural aspects (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2015/158/20151215#prilohy.priloha-priloha_c_3_k_vyhlaske_c_158_2015_z_z.op-skupinaElementov_poziadavky_na_informacie.op-cast_b)
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