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 18, 2026
Approximately 5 minutes
Slovakia Decree No. 158/2015 Annex 3 Part A: Information Requirements for Class I Medical Devices
Slovakia Decree No. 158/2015 Annex 3 Part A: Information Requirements for Class I Medical Devices
1. Legal Basis and Scope
Part A of Annex 3 (Príloha č. 3 – časť A) to Decree No. 158/2015 Z.z. details the information obligations for Class I medical devices under the Slovak transposition of Directive 93/42/EEC (MDD). It applies to self-declared Class I devices (including sterile, measuring or reusable surgical instruments) when placed on the market or notified to the State Institute for Drug Control (ŠÚKL). These requirements remain relevant for legacy devices during the MDR transitional period. Source: Decree No. 158/2015 Z.z. Annex 3 Part A (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_a)
2. Registration/Notification Obligation for Class I
Class I devices require prior notification to ŠÚKL before first placing on the market (except non-sterile, non-measuring, non-reusable surgical). The manufacturer or authorised representative submits the required information package. ŠÚKL issues a registration number upon successful submission. Source: Decree No. 158/2015 Z.z. Annex 3 Part A introductory 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_a)
3. Mandatory Information Elements
The submission must include:
- Manufacturer identification (name, address, contact)
- Authorised representative details (if applicable)
- Device name, model(s), catalogue number(s)
- Intended purpose and classification rationale (with reference to Annex 1 rules)
- Declaration of conformity (signed)
- List of applied harmonised standards
- Risk analysis summary and risk management report excerpt
- Labelling and instructions for use (in Slovak language)
- Sterilisation validation data (for sterile devices)
- Measuring function validation (for measuring devices)
Source: Decree No. 158/2015 Z.z. Annex 3 Part A points 1–10 (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_a)
4. Language and Format Requirements
- All documents must be submitted in Slovak or with certified Slovak translation.
- Technical documentation excerpts (risk management, validation) may be in English with key summaries translated.
- Submission is typically electronic via ŠÚKL portal.
Source: Decree No. 158/2015 Z.z. Annex 3 Part A general 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_a)
5. Changes Requiring Re-notification
Significant changes to the device (intended purpose, design affecting safety, labelling) require updated information submission and re-notification to ŠÚKL. Minor administrative changes may only need notification without full re-submission. Source: Decree No. 158/2015 Z.z. Annex 3 Part A 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_a)
6. Transitional Considerations under MDR
For legacy Class I devices under MDD transitional rules (MDR Art. 120), continued compliance with these Annex 3 Part A requirements applies until expiry of MDD certificate or full MDR application. New Class I devices follow MDR registration/notification via EUDAMED. Source: Decree No. 158/2015 Z.z. Annex 3 Part A (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_a)
7. Practical Guidance for RA Managers
- Prepare a complete Class I notification dossier using Annex 3 Part A as checklist.
- Ensure Slovak labelling and IFU are ready before submission.
- Include clear justification linking intended use to Annex 1 rule(s) for Class I.
- Maintain version control for any post-notification changes.
- Use ŠÚKL electronic system for faster processing.
- Archive confirmation of registration number and submission receipt.
Source: Decree No. 158/2015 Z.z. Annex 3 Part A (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_a)
8. Common Documentation Pitfalls
- Incomplete risk management summary → rejected submission.
- Missing Slovak translation of key parts → delay or request for correction.
- Unclear classification rationale → potential reclassification request.
- Failure to update on changes → compliance breach.
Source: Decree No. 158/2015 Z.z. Annex 3 Part A practical application 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_a)
9. ŠÚKL Review Process
ŠÚKL verifies completeness and basic compliance within statutory timelines (typically 30 days). Registration number is issued upon acceptance. ŠÚKL may request clarifications or additional data. Source: Decree No. 158/2015 Z.z. Annex 3 Part A 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_a)
10. Alignment with MDR Self-Declaration
Under full MDR, Class I devices remain self-declared without prior authority notification (except sterile/measuring Class I requiring conformity assessment). Manufacturers transitioning legacy devices should plan for reduced notification burden but increased PMS documentation. Source: Decree No. 158/2015 Z.z. Annex 3 Part A (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_a)
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 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 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 Decree No. 158/2015 Annex 3 Part B: Documentation Obligations for Class IIa/IIb/III Devices
Annex 3 Part B of Decree No. 158/2015 Z.z. details the comprehensive documentation and information that manufacturers and authorized representatives must submit to ŠÚKL for higher-risk medical devices (Class IIa, IIb, III) in Slovakia, including certificates, technical summaries, risk management excerpts, labelling in Slovak, and vigilance data, under the MDD-transposed regime.
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.