Want real case studies? 10 seconds to sign up
Join the platform
January 5, 2026
Approximately 5 minutes
Reviewed by Nate Lam, Founder & Director, ElendiLabs
Slovakia Act No. 362/2011 §103: Authorized Representative Registration and Notification Requirements
1. Legal Provision Overview
Section 103 requires any person established in Slovakia intending to act as an authorized representative for a manufacturer not established in the European Union to:
- Register with the State Institute for Drug Control (ŠÚKL) prior to commencing activities
- Notify ŠÚKL of any changes in registration particulars
- Annually confirm continuation of the authorization
This provision transposes MDD Article 10 obligations for local representation. Source: Act No. 362/2011 Coll. §103 (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-103)
2. Who Must Register
Registration is mandatory for:
- Natural or legal persons with registered office or place of business in Slovakia
- Acting as authorized representative for non-EU manufacturers
- Representing any class of medical devices (I to III, including custom-made)
Foreign-based ARs without Slovak establishment are not covered by this section. Source: Act No. 362/2011 Coll. §103 (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-103)
3. Registration Process and Content
The registration application to ŠÚKL must include:
- Identification of the authorized representative (name, address, company registration)
- List of represented non-EU manufacturers
- Scope of represented devices (classes, types)
- Contact details for vigilance and technical documentation
ŠÚKL issues a registration confirmation upon compliance. Source: Act No. 362/2011 Coll. §103 (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-103)
4. Notification of Changes
The authorized representative must notify ŠÚKL without undue delay of:
- Changes in identification, address, or legal form
- Addition or removal of represented manufacturers
- Changes in scope of represented devices
- Termination of authorization for any manufacturer
Failure to notify may lead to sanctions or deregistration. Source: Act No. 362/2011 Coll. §103 (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-103)
5. Annual Confirmation Requirement
Each year, the authorized representative must submit to ŠÚKL:
- Confirmation that the authorization continues for each represented manufacturer
- Updated list of manufacturers and device scopes if changed
- Statement of compliance with AR obligations
This serves as ongoing verification of active representation. Source: Act No. 362/2011 Coll. §103 (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-103)
6. MDR Transition Application
For legacy devices under MDD transitional provisions (MDR Article 120):
- §103 registration and notification duties continue until MDD certificate expiry
- After transition, MDR Article 11 requires similar but more detailed AR registration in EUDAMED
- Slovak ARs must prepare for dual compliance during transition
Source: Act No. 362/2011 Coll. §103 (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-103)
7. Practical RA Guidance for ARs
- Maintain a dedicated Slovak registration file with all submissions to ŠÚKL
- Set calendar reminders for annual confirmation (typically by end of Q1)
- Implement change control process for manufacturer additions/removals
- Keep evidence of ŠÚKL confirmations and notifications for audits
- Coordinate with non-EU manufacturers to ensure timely updates
- Prepare for potential ŠÚKL verification audits
Source: Act No. 362/2011 Coll. §103 (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-103)
8. Common Compliance Issues
- Failure to notify manufacturer termination promptly
- Incomplete annual confirmation submissions
- Outdated registration details after company changes
- Missing documentation of ŠÚKL confirmations
- Delays in notifying scope expansions
Source: Act No. 362/2011 Coll. §103 practical notes (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-103)
9. Enforcement and Risks
Non-compliance with §103 may result in:
- Administrative fines
- Order to cease representing manufacturers
- Deregistration as authorized representative
- Potential impact on market access for represented devices
Source: Act No. 362/2011 Coll. enforcement provisions (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-103)
10. Alignment with MDR AR Registration
While §103 implements MDD AR registration, MDR Article 11 introduces:
- Mandatory EUDAMED registration for ARs
- Stricter verification of manufacturer compliance
- Person responsible for regulatory compliance requirement
- Enhanced annual reporting obligations
Authorized representatives should align Slovak duties with MDR expectations. Source: Act No. 362/2011 Coll. §103 (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-103)
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.
Registered Pharmacist · AI Engineer · Director, ElendiLabs
Registered pharmacist, AI engineer, HKHAIS founder, and pharmaceutical & medical device SEO/GEO specialist.
Ask Anything
We'll follow up with you personally.
100% response rate • Reply within 7 business days
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 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 §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 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.