In Croatia, the governmental body responsible for regulating medical devices is the Agency for Medicinal Products and Medical Devices (HALMED). As a member of the European Union since July 2013, Croatia follows the EU MDR 2017/745 framework for medical device regulation and market access.
Device Classification
Medical devices are classified into four risk-based categories: Class I, Class IIa, Class IIb, and Class III, with each class representing a progressively higher level of risk to the human body. Classification is governed by Annex VIII of EU MDR 2017/745 and takes into account factors such as intended purpose, duration of use, invasiveness, and whether the device is active or implantable.
CE Marking and Conformity Assessment
CE marking under EU MDR is required to place a medical device on the Croatian market. For Class I devices that are non-sterile, have no measuring function, and are not reusable surgical instruments, manufacturers may self-declare conformity. All other device classes, including sterile Class I devices, Class I devices with a measuring function, reusable surgical instruments, and all Class IIa, IIb, and III devices, require involvement of a Notified Body in the conformity assessment process.
Notified Body certificates do not carry a fixed five-year validity under MDR. Certificate duration is determined by the Notified Body based on device class and scope, and manufacturers must maintain ongoing compliance through surveillance audits throughout the certificate period.
EUDAMED Registration: Critical 2026 Deadlines
From May 28, 2026, EUDAMED registration is mandatory for four confirmed functional modules: Actor Registration, UDI and Device Registration, Notified Bodies and Certificates, and Market Surveillance. These obligations apply to all EU member states, including Croatia, and replace many of the former national notification processes.
Key deadlines manufacturers must be aware of:
New MDR and IVDR devices must be registered in EUDAMED before being placed on the market from 28 May 2026 onward. Legacy devices and devices already on the market before that date must be registered in EUDAMED by November 18, 2026. Notified Body certificates issued before May 28, 2026 must be uploaded to EUDAMED by May 28, 2027.
All manufacturers must register as an economic operator in EUDAMED and obtain a Single Registration Number (SRN) before placing devices on the market. Prior to the May 28, 2026 deadline, HALMED must still be notified of devices being placed on the Croatian market within 15 days of placement, as has been the national requirement.
Authorized Representative
Manufacturers located outside the European Union or the European Economic Area must appoint an EU Authorized Representative. The Authorized Representative must have a registered place of business in an EU member state and is registered in the Croatian register of medical device manufacturers on behalf of the non-EU manufacturer. The Authorized Representative holds legally defined responsibilities under MDR and serves as the primary point of contact for HALMED and other national competent authorities.
Language Requirements
All labeling and Instructions for Use must be in Croatian. Under the Croatian Implementation Act, all information and documentation intended for patients and lay persons must be presented in the Croatian language. This includes device labels and IFUs for foreign manufacturers entering the Croatian market. Technical documentation and the Declaration of Conformity submitted to HALMED may be accepted in English, but manufacturers are advised to confirm current requirements directly with HALMED. For implantable devices, MDR additionally requires that an implant card be provided to the patient free of charge, and this card must also be in Croatian.
Quality Management System
A Quality Management System certified to ISO 13485 is required. Local technical testing is not required, but a Clinical Evaluation Report is required for all device classes in accordance with EU MDR requirements.
Registration Timeline
The registration process takes approximately 4 to 6 weeks after submission for Class I devices not requiring Notified Body involvement. For higher-class devices, the timeline depends on the Notified Body contract and the complexity of the device.
Key Takeaways for 2026
To successfully commercialize a medical device in Croatia, manufacturers should ensure full compliance with EU MDR, obtain valid CE marking, complete EUDAMED economic operator and device registration ahead of the May 28, 2026 mandatory deadline (with legacy devices requiring registration by November 28, 2026), appoint an EU Authorized Representative if located outside the EU, meet Croatian language requirements for labeling and Instructions for Use, implement a documented post-market surveillance plan including Periodic Safety Update Reports where required under MDR Article 86, and monitor ongoing European Commission efforts to simplify the MDR and IVDR frameworks, as amendments may affect compliance obligations during 2026 and beyond.
With heightened scrutiny across EU markets, manufacturers must move beyond basic compliance and adopt centralized regulatory systems to manage submissions, surveillance, and documentation efficiently.
