🇦🇱Albania Medical Device Regulations

Law on Medical Devices

Primary Albanian law governing medical device market placement, registration, conformity assessment, distribution, inspection, and surveillance, including IVDs and active implantable devices.

Amendments to the Albanian Medical Devices Law

Updates Law 89/2014 and partially aligns Albanian medical device definitions and obligations with Regulation (EU) 2017/745.

Medical Device, Active Implantable and IVD Technical Rules

AKBPM technical rules covering essential requirements, conformity assessment, classification, and CE marking for general medical devices, active implantables, and IVDs.