MDR & IVDR national implementation: Malta

The Medicines Act 2020 "Medical Devices and In-Vitro diagnostic Medical Devices Provision on the Maltese Market Regulations" implements the EU Regulations on medical devices and in vitro diagnostic medical devices in Malta.

Among others, the Act addresses designation of competent authorities, importation, wholesaling, manufacturing, and re-purposing of medical devices, obligations for registered person and economic operators, issuing of approval and guidelines, monitoring and review of operations, and fines and penalties.
Designation of competent authority and accrediting body
Article 3 of the Act defines . . .


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