Medical Device Regulation in Slovakia
Slovakia regulates medical devices under the EU Medical Device Regulation (EU MDR 2017/745) as an EU member state. The State Institute for Drug Control (ŠÚKL) serves as the national competent authority for medical devices. Slovakia's regulatory framework is fully harmonized with EU requirements, ensuring consistent device safety and performance standards across the European market.
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Device Classification
Slovakia follows the EU MDR Annex VIII classification rules. Class I covers low-risk devices such as walking aids and adhesive bandages. Class IIa includes medium-risk devices such as dental fillings and electrocardiographs. Class IIb covers higher-risk devices such as anaesthetic machines and radiation therapy devices. Class III includes the highest-risk devices such as coronary stents and implantable neurostimulators.
Official classification guidance →Standards & Key Principles
Applicable Standards
Key Principles
- CE marking under EU MDR 2017/745 is mandatory for all medical devices placed on the Slovak market.
- Economic operators must register with ŠÚKL before placing devices on the market.
- Slovak language labeling and instructions for use are required for devices intended for lay users.
- Clinical investigations require ŠÚKL authorization and ethics committee approval.
- ŠÚKL participates in EU coordinated market surveillance and vigilance activities.
Pre-Market Requirements
Manufacturers must complete EU MDR conformity assessment procedures. Notified Body involvement is required for Class IIa, IIb, and III devices.
CE marking is mandatory before placing any medical device on the Slovak market.
Manufacturers, authorized representatives, and importers must register with ŠÚKL and notify the authority of devices placed on the Slovak market.
Complete technical documentation per EU MDR Annexes II and III must be prepared and maintained, including clinical evaluation and risk management files.
Post-Market Requirements
Manufacturers must maintain PMS systems proportionate to device risk class, as required by EU MDR Chapter VII.
Serious incidents and field safety corrective actions must be reported to ŠÚKL in accordance with EU MDR vigilance requirements.
PSURs are required for Class IIa, IIb, and III devices, summarizing PMS data and benefit-risk assessments at defined intervals.
ŠÚKL conducts market surveillance activities including inspections and compliance checks on devices circulating in the Slovak market.
International Recognition & Reliance
As an EU member state, Slovakia fully applies the EU MDR and recognizes CE-marked devices certified by any EU-designated Notified Body.