IRIS / For manufacturers
For manufacturers
IRIS supplies hospitals, clinics and laboratories in Albania with medical devices, in vitro diagnostics and related software.
Existing authorised relationships
Local market execution
IRIS manages the route from regulatory and import procedures through installation, training and technical follow-up.
Registered since 1993
IRIS is registered for the wholesale trade of medical devices in Albania. The company has been registered since 1993.
Eight clinical areas
The portfolio spans cardiology, fertility, gynaecology and laboratory medicine, across eight supply areas.
The full service cycle
We supply, install, service and train clinical staff for every product we bring in, and handle the regulatory procedure through to delivery.
Clinical research in Albania
IRIS is prepared to support clinical research in Albania as a contract research organisation (CRO), with local coordination, supply and technical assistance on request. This is service preparedness, not a claim of completed-study experience.
Why a local base matters
EU convergence
Albania has opened all 33 EU accession chapters and provisionally closed Chapter 25 on Science and Research in July 2026. This establishes a direction of reform; it does not make Albania an EU Member State or part of the EEA.
Albanian requirements
Clinical investigations of devices conducted in Albania follow Albanian authorisation and ethics review. Law no. 124/2024 may require a controller or processor outside Albania to appoint a representative in Albania where the law's territorial scope applies and no exception is available.
Local execution
Work in Albania requires site relationships, local documentation, authority coordination and, where relevant, import handling. IRIS is an Albanian entity prepared for those processes and for technical support around a study.
Albania is outside the EEA. CTIS and Regulation (EU) 536/2014 apply to trials in the EU/EEA; an Albanian entity such as IRIS does not replace the legal representative required in the European Union.
Supply beyond Albania
In Albania, IRIS already supplies public and private hospitals, clinics, fertility centres and laboratories.
Supply can extend beyond Albania where Albanian law and our agreements with manufacturers allow it.