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January 20, 2026
Approximately 5 minutes
Slovakia Decree No. 158/2015 Annex 3 Part B: Information Requirements for Higher Risk Medical Devices
Slovakia Decree No. 158/2015 Annex 3 Part B: Information Requirements for Higher Risk Medical 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 information obligations for medical devices of Class IIa, IIb and III when placed on the market or notified to the State Institute for Drug Control (ŠÚKL). It transposes the higher-risk device requirements from Directive 93/42/EEC (MDD) Annex II/III/V/VI and remains applicable for legacy devices during the MDR transitional period. 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. Scope of Devices Covered
This part applies to:
- All Class IIa, IIb and III devices (invasive, active, implantable, etc.)
- Devices incorporating medicinal substances or biological tissues
- Sterile Class I devices requiring notified body involvement
- Measuring Class I devices with certification
Self-declared non-sterile/non-measuring Class I devices are excluded (see Part A). Source: Decree No. 158/2015 Z.z. Annex 3 Part B introductory 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. Core Information and Documentation Requirements
The submission must include:
- Manufacturer and authorised representative details
- Full device identification (name, models, UDI if applicable)
- Intended purpose and detailed classification justification
- Signed EC Declaration of Conformity
- Notified body certificate(s) (full text or certified copy)
- Technical documentation summary (design, risk management per ISO 14971, essential requirements checklist)
- Labelling, instructions for use and promotional materials (in Slovak)
- Vigilance history summary and any ongoing FSCA/FSN
- Periodic safety update report or equivalent post-market surveillance data (for ongoing surveillance)
Source: Decree No. 158/2015 Z.z. Annex 3 Part B main points (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 Requirements for Certain Devices
- Devices with medicinal substance → Include pharmaceutical data and interaction studies
- Devices incorporating human/animal tissues → Provide origin, processing and TSE/BSE risk assessment
- Active implantable devices → Submit AIMD-specific documentation
- Software as medical device → Include software lifecycle documentation and validation
Source: Decree No. 158/2015 Z.z. Annex 3 Part B special categories (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, Format and Submission
- Primary language: Slovak (certified translations required for original foreign documents)
- Technical excerpts: English acceptable with Slovak summaries for key safety aspects
- Submission: Electronic via ŠÚKL portal; paper only if expressly requested
Source: Decree No. 158/2015 Z.z. Annex 3 Part B submission 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 Triggering Re-submission
Significant changes (affecting safety, performance, intended use or risk classification) require full or partial re-submission. Minor changes (administrative, non-safety labelling) need notification only. Source: Decree No. 158/2015 Z.z. Annex 3 Part B change notification (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. Transitional Application under MDR
Legacy higher-risk devices continue to follow these Annex 3 Part B requirements during the MDD certificate validity period (MDR Art. 120). Full MDR application shifts documentation obligations to Annex II/III of MDR and EUDAMED registration. 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
- Compile notified body certificates and full DoC
- Prepare Slovak-language labelling/IFU package
- Include comprehensive risk management file summary
- Attach vigilance/PSUR excerpts for ongoing surveillance
- Document any special material (medicinal/biological) assessments
- Submit via ŠÚKL portal and retain confirmation
- Track certificate expiry for MDR transition 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. Common Submission Issues
- Incomplete technical documentation summary → request for additional data
- Missing or outdated notified body certificate → rejection
- Inadequate Slovak translation → delay until corrected
- Lack of vigilance history for established devices → potential follow-up questions
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 Processing and Outcomes
ŠÚKL reviews for completeness and basic compliance (typically 30–90 days depending on complexity). Upon acceptance, registration is confirmed (higher-risk devices often receive market surveillance follow-up). Non-compliance may lead to refusal or conditional acceptance with deadlines. Source: Decree No. 158/2015 Z.z. Annex 3 Part B review process (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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