Need Regulatory Help? Try Our Platform
Post your regulatory questions or request quotations from verified pharmaceutical consultants worldwide. Get matched with experts who specialize in your market.
January 5, 2026
Approximately 5 minutes
Slovakia Decree No. 158/2015 Annex 3 Part B: Documentation Obligations for Class IIa/IIb/III Devices
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)
Ask Anything
We'll follow up with you personally.
Related Articles
Approximately 5 minutes
Slovakia Decree No. 158/2015 Annex 10: Post-Market Surveillance and Vigilance Reporting Obligations for Medical Devices
Annex 10 to Decree No. 158/2015 Z.z. outlines the mandatory post-market surveillance (PMS), vigilance reporting, trend analysis, periodic safety update reports (PSUR), and field safety corrective action (FSCA) requirements for medical devices in Slovakia, transposed from MDD Annex II/III/V/VI and applicable to legacy devices during MDR transition.
Approximately 5 minutes
Slovakia Act No. 362/2011 §6(1)(c): Definition and Scope of Custom-Made Medical Devices
Section 6(1)(c) of Slovak Act No. 362/2011 defines custom-made medical devices as those manufactured specifically according to a written prescription from a qualified healthcare professional to meet the unique needs of an individual patient, distinguishing them from mass-produced devices and exempting them from standard registration under certain conditions.
Approximately 5 minutes
Slovakia Decree No. 158/2015 Annex 1: Classification Rules for Medical Devices
Annex 1 to Slovak Decree No. 158/2015 Z.z. sets out the detailed classification rules for medical devices in Slovakia, implementing the classification criteria of EU Directive 93/42/EEC (Annex IX), including 18 rules covering non-invasive, invasive, active devices, and special cases such as software and combination products, used to determine Class I, IIa, IIb or III.
Approximately 5 minutes
Slovakia Act No. 362/2011 §141(1)(b): Vigilance Reporting Obligations for Serious Incidents
Under §141(1)(b) of Act No. 362/2011 Coll., manufacturers, authorised representatives, importers and distributors in Slovakia must immediately report to the State Institute for Drug Control (ŠÚKL) any serious incident or field safety corrective action involving a medical device, including details of the event, risk assessment and proposed measures, to ensure rapid response and patient safety.
Approximately 5 minutes
Slovakia Decree No. 158/2015 Annex 2: List of Classified Medical Devices and Examples
Annex 2 to Decree No. 158/2015 Z.z. provides a non-exhaustive illustrative list of medical devices with their assigned risk classes in Slovakia, based on the classification rules of Annex 1 (transposing MDD Annex IX), serving as a practical reference for manufacturers and RA professionals to determine conformity assessment requirements for common device types.
Approximately 5 minutes
Slovakia Decree No. 158/2015 Annex 3 Part A: Information Requirements for Class I Medical Devices
Annex 3 Part A of Decree No. 158/2015 Z.z. specifies the mandatory information that manufacturers must provide to the State Institute for Drug Control (ŠÚKL) when registering or notifying Class I medical devices in Slovakia, including device details, classification justification, risk management summary, labelling, and instructions for use, as transposed from MDD requirements.
Approximately 5 minutes
Slovakia Decree No. 158/2015 Annex 3 Part B: Information Requirements for Higher Risk Medical Devices
Annex 3 Part B of Decree No. 158/2015 Z.z. outlines the detailed information and documentation that manufacturers must submit to ŠÚKL for Class IIa, IIb and III medical devices in Slovakia, including full technical documentation excerpts, conformity assessment certificates, vigilance summaries and periodic safety update reports, as required under the MDD framework.
Approximately 5 minutes
Slovakia Decree No. 158/2015 Annex 5 Part A §1(e): Mandatory Anti-HBc Testing for Blood Donors
Under Annex 5 Part A §1(e) of Decree No. 158/2015 Z.z., all blood donors in Slovakia must undergo mandatory testing for antibodies to hepatitis B core antigen (anti-HBc) as part of the required infectious marker screening to ensure blood safety and prevent HBV transmission via transfusion.
Approximately 5 minutes
Slovakia Decree No. 158/2015 Annex 6: Requirements for Clinical Evaluation and Performance Studies of IVDs
Annex 6 to Decree No. 158/2015 Z.z. establishes the detailed requirements for clinical evaluation, performance studies, scientific validity, analytical and clinical performance of in vitro diagnostic medical devices (IVDs) in Slovakia, transposing key elements of Directive 98/79/EC Annex III and serving as guidance for manufacturers during the IVDR transitional period.
Approximately 5 minutes
Slovakia Act No. 362/2011 §141(1)(b): Mandatory Serious Incident Reporting for Medical Devices
Section 141(1)(b) of Act No. 362/2011 Coll. imposes an immediate reporting duty on manufacturers, authorised representatives, importers and distributors to notify the State Institute for Drug Control (ŠÚKL) of any serious incident or field safety corrective action involving a medical device placed on the Slovak market, ensuring rapid national response and patient protection under the MDD-transposed framework.
Approximately 5 minutes
Slovakia Act No. 362/2011 §6(4)(f)(1): Exemption from Registration for Custom-Made Medical Devices
Under Slovak Act No. 362/2011 on Medicinal Products and Medical Devices, custom-made medical devices are exempt from registration with the State Institute for Drug Control (ŠÚKL) if they meet specific conditions under §6(4)(f)(1), allowing faster market access for patient-specific devices while maintaining manufacturer responsibility for safety and documentation.
Approximately 5 minutes
Slovakia Decree No. 158/2015 Annex 8: Requirements for Sterilisation Validation of Medical Devices
Annex 8 to Decree No. 158/2015 Z.z. sets out the mandatory sterilisation validation and assurance requirements for sterile medical devices in Slovakia, including process validation, sterility assurance level (SAL), packaging, labelling, and periodic revalidation, transposed from MDD Annex I essential requirements and harmonised standards.
Approximately 5 minutes
Slovakia Decree No. 158/2015 §2(2): Definition of Medical Device and Scope of Regulation
Section 2(2) of Decree No. 158/2015 Z.z. provides the precise legal definition of a 'medical device' in Slovakia, including key criteria such as intended purpose, principal intended action, and exclusions, serving as the foundational scope for all regulatory obligations under the MDD-transposed framework.
Approximately 5 minutes
Slovakia Act No. 362/2011 §141(1)(b): Immediate Reporting Duty for Serious Incidents and FSCA
Under §141(1)(b) of Act No. 362/2011 Coll., manufacturers, authorised representatives, importers and distributors must immediately notify ŠÚKL of any serious incident or field safety corrective action involving a device on the Slovak market, transposing MDD vigilance requirements and applicable to legacy devices in the MDR transition.
Approximately 5 minutes
Slovakia Act No. 362/2011 §124a(4)(d): Authorized Representative Obligations for Foreign Manufacturers
Section 124a(4)(d) of Act No. 362/2011 Coll. requires the authorized representative of a non-EU manufacturer to keep available and provide upon request to ŠÚKL the technical documentation, declaration of conformity, and certificates for medical devices placed on the Slovak market, ensuring regulatory oversight and traceability under the MDD-transposed framework.
Approximately 5 minutes
Slovakia Act No. 362/2011 §103: Authorized Representative Registration and Notification Requirements
Section 103 of Act No. 362/2011 Coll. mandates that authorized representatives established in Slovakia must register with ŠÚKL before commencing activities, notify changes in registration details, and provide annual confirmations of continued authorization for non-EU manufacturers under the MDD-transposed regime.
Approximately 5 minutes
Slovakia Act No. 362/2011 §124b(6): Joint Liability of Authorized Representative for Defective Medical Devices
Section 124b(6) of Act No. 362/2011 Coll. establishes joint and several liability of the authorized representative with the non-EU manufacturer for any damage caused by defective medical devices placed on the Slovak market, transposing product liability protections under the MDD framework.
Approximately 5 minutes
Slovakia Act No. 362/2011 §126(5): Distributor Obligations for Medical Device Compliance Verification
Section 126(5) of Act No. 362/2011 Coll. mandates distributors to verify that medical devices comply with regulatory requirements, including conformity marking, labelling, and instructions in Slovak, before distribution in Slovakia, ensuring market surveillance under the MDD-transposed regime.
Approximately 5 minutes
Slovakia Act No. 362/2011 §46(5): Authorized Representative Notification of Serious Incidents
Section 46(5) of Act No. 362/2011 Coll. requires the authorized representative to immediately notify the competent authority (ŠÚKL) of any serious incident involving a medical device placed on the Slovak market, ensuring rapid vigilance reporting under the MDD-transposed framework.
Approximately 5 minutes
Slovakia Act No. 362/2011 §46(4): Authorized Representative Record-Keeping and Documentation Duties
Section 46(4) of Act No. 362/2011 Coll. requires the authorized representative to keep and make available to the competent authority all relevant documentation concerning the medical devices for which he acts as representative, including technical files, declarations of conformity, and vigilance records, ensuring traceability under the MDD-transposed regime.