Medical Device Regulation in Slovenia
Slovenia regulates medical devices under the EU Medical Device Regulation (EU MDR 2017/745) as an EU member state. The Agency for Medicinal Products and Medical Devices (JAZMP) is the national competent authority. Slovenia maintains full alignment with EU regulatory requirements and actively participates in coordinated European market surveillance initiatives.
Recent Regulatory Updates
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JAZMP webinar on MDR/IVDR duties for health institutions
New JAZMP tariff for medical device fees.
Sources Tracked by Qalico
Qalico continuously monitors 1 references across guidelines, regulations, and standards for Slovenia.
Regulations
Device Classification
Slovenia applies the EU MDR Annex VIII classification rules. Class I covers low-risk devices such as non-invasive examination aids and reusable surgical instruments. Class IIa includes medium-risk devices such as contact lenses and hearing aids. Class IIb covers higher-risk devices such as ventilators and infusion pumps. Class III includes the highest-risk devices such as cardiac pacemakers and hip replacement systems.
Official classification guidance →Standards & Key Principles
Applicable Standards
Key Principles
- CE marking under EU MDR 2017/745 is mandatory for all medical devices on the Slovenian market.
- Economic operators must register with JAZMP before placing devices on the market.
- Slovenian language labeling and instructions for use are required where applicable.
- Clinical investigations conducted in Slovenia require JAZMP authorization and ethics committee approval.
- Slovenia participates in EU-wide coordinated market surveillance programs.
Pre-Market Requirements
Manufacturers must complete conformity assessment per EU MDR procedures, with Notified Body involvement required for Class IIa, IIb, and III devices.
CE marking is required before placing any medical device on the Slovenian market.
Economic operators must register with JAZMP and notify the authority of devices placed on the Slovenian market.
Complete technical documentation per EU MDR Annexes II and III must be prepared and maintained by the manufacturer.
Post-Market Requirements
Manufacturers must maintain PMS systems in compliance with EU MDR Chapter VII requirements.
Serious incidents and field safety corrective actions must be reported to JAZMP per EU MDR vigilance requirements.
PSURs are required for Class IIa, IIb, and III devices, containing a systematic analysis of PMS data.
International Recognition & Reliance
As an EU member state, Slovenia fully applies the EU MDR and recognizes CE-marked devices certified by any EU-designated Notified Body.