Medical Devices Register

Register of persons responsible for placing medical devices, active implantable medical devices, and in vitro diagnostic medical devices on the market.

The manufacturer or their authorized representative registers information about Class I risk in vitro diagnostic devices not included in List A and List B of Technical Regulation 754 and not intended for self-testing.

Information is entered into the Register by submitting notifications, declarations of conformity, and certificates of conformity through the Responsible Person’s Office.

Medical devices of Class IIa, IIb, III, in vitro diagnostic devices from List A, List B, or for self-testing are not registered but undergo conformity assessment by the relevant notified body and receive a certificate of conformity.