Medical Device Regulation in Croatia
Croatia 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 (HALMED) is the national competent authority. Croatia joined the EU in 2013 and has progressively aligned its medical device regulatory framework with the EU harmonized system.
Sources Tracked by Qalico
Qalico continuously monitors 55 references across guidelines, regulations, and standards for Croatia.
Regulations
Device Classification
Croatia follows the EU MDR classification system. Class I devices are low risk (e.g., tongue depressors, reusable scalpels). Class IIa devices are low-moderate risk (e.g., powered hearing aids, blood glucose monitors). Class IIb devices are moderate-high risk (e.g., ventilators, bone screws). Class III devices are high risk (e.g., spinal disc replacements, drug-coated balloons). Classification follows EU MDR Annex VIII.
Official classification guidance →Official Guidance Documents
Official HALMED portal for medical device regulation in Croatia, including registration, vigilance, and regulatory guidance.
The complete text of EU Regulation 2017/745 on medical devices, directly applicable in Croatia.
The European database for medical device registration and UDI management across all EU member states.
Standards & Key Principles
Applicable Standards
Key Principles
- Medical devices must bear the CE mark under EU MDR 2017/745 to be placed on the Croatian market.
- EUDAMED registration and UDI compliance are required.
- Notified body involvement is mandatory for Class IIa, IIb, and III devices.
- Non-EU manufacturers must appoint an EU-based authorized representative.
- Post-market surveillance and vigilance reporting to HALMED are mandatory obligations.
Pre-Market Requirements
Devices must comply with EU MDR 2017/745 and bear the CE mark. Notified body assessment is required for Class IIa, IIb, and III devices.
Full technical documentation per EU MDR Annexes II and III must be prepared and maintained.
Clinical evaluations are mandatory for all device classes. Clinical investigations in Croatia require HALMED authorization and ethics committee approval.
Manufacturers must register in EUDAMED with actor, device, and UDI information.
Post-Market Requirements
PMS systems must be maintained per EU MDR requirements. PSURs are required for Class IIa, IIb, and III devices.
Serious incidents and field safety corrective actions must be reported to HALMED per EU MDR Article 87.
Ongoing PMCF activities are required to continuously validate device safety and performance.
International Recognition & Reliance
As an EU member state, CE-marked devices are recognized across all EU/EEA member states.
CE-marked devices from EU member states are recognized in Switzerland under the MRA framework.