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Overview of the State Institute for Drug Control (ŠÚKL) and Medical Device Regulation in Slovakia

An overview of ŠÚKL's role as the competent authority for medical devices in Slovakia, covering registration, vigilance, and market surveillance.

Overview

Summary of this regulator or jurisdiction and how it relates to market access.

Official regulator site

State Institute for Drug Control (ŠÚKL) - Medical Devices Overview

The State Institute for Drug Control (ŠÚKL) is the national competent authority responsible for the supervision of medical devices in the Slovak Republic. The Medical Devices Section of ŠÚKL ensures that products on the Slovak market meet safety, efficacy, and quality standards.

Key Roles and Responsibilities

Registration and Notification: ŠÚKL manages the registration of manufacturers and the notification of medical devices (Class IIa, IIb, and III) before they are placed on the Slovak market.
Vigilance (Materiovigilance): The institute monitors adverse incidents and handles reports from manufacturers and healthcare providers to ensure ongoing patient safety.
Market Surveillance: Performs both proactive and reactive inspections of medical devices to verify compliance with European and national legislation.
Code Assignment: Upon successful notification, ŠÚKL assigns unique codes to devices, which are essential for reimbursement by health insurance companies and for sale in pharmacies.
Clinical Investigations: Reviews and authorizes clinical trials for medical devices conducted in Slovakia.

Notification Requirements

To notify a device in Slovakia, the following are typically required:

Language: Instructions for Use (IFU) and labeling must be provided in the Slovak language.
Documentation: EC Declaration of Conformity, CE Certificates, and a Power of Attorney (if using a local representative).
Cost: The notification procedure in Slovakia is currently cost-free.

Regulatory Framework

ŠÚKL operates under the EU Medical Device Regulation (MDR) 2017/745 and In Vitro Diagnostic Regulation (IVDR) 2017/746, integrated into national law via Act No. 362/2011 Coll.

Articles & guides

Insight articles mapped to this region on ElendiLabs.

Post Market Surveillance

February 20, 2026

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.

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Registration

February 1, 2026

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.

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Post Market Surveillance

January 30, 2026

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.

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Registration

January 25, 2026

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.

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Registration

January 25, 2026

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.

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Registration

January 22, 2026

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.

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Registration

January 22, 2026

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.

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Other

January 20, 2026

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.

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Registration

January 20, 2026

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.

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Registration

January 18, 2026

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.

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Other

January 15, 2026

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.

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Registration

January 15, 2026

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.

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Post Market Surveillance

January 15, 2026

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.

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Clinical Trials

January 15, 2026

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.

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Registration

January 12, 2026

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.

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Registration

January 10, 2026

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.

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Post Market Surveillance

January 10, 2026

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.

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Registration

January 5, 2026

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.

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Registration

January 5, 2026

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.

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Registration

January 5, 2026

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.

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Registration

October 28, 2025

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.

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