Malta

Ministry of Health:     

Ministry of Health

Regulatory Authority:          

Malta Medicine Authority

Medical Device Regulation:          

Medical Devices And In-Vitro Diagnostic Medical Devices Provision On The Maltese Market Regulations S.L.458.59

EU MDR 2017/745

Official Language:      

Maltese, English

Classification:    

Class I, IIa, IIb and III

Registration Process:

• Determine the device classification
• Appoint Authorized representative and Notified Body
• All devices must bear a CE mark
• The Notified Body audits the manufacturer for Conformity Assessment.
• The Notified body submits the documentation to the Competent Authority
• Once approved, the device can be marketed