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Manufacturers applying to register a medical device or IVD with the Australian Register of Therapeutic Goods (ARTG) now have more options to leverage to fulfill the Manufacturer Evidence requirement to support an application. As a result, manufacturers may leverage their EU CE Marking Certificate issued under the IVDD to fulfill the Manufacturer Evidence requirement until the dates listed below...

1. Introduction The transitional provisions of Regulation (EU) 2017/745 on medical devices (MDR) have been amended by Regulation (EU) 2023/607. In particular, the transitional period has been extended from 26 May 2024 until 31 December 2027 or 31 December 2028, depending on the risk class of the device and subject to certain conditions. This document provides updated guidance as regards the appl..

According to Regulation (EU) 2017/746 on in vitro diagnostic medical devices (the IVDR), as part of conformity assessment of class D in vitro diagnostic medical devices (IVDs), the manufacturer must submit an application to a notified body. In addition to the assessment by the notified body, under certain conditions particular elements may be reviewed by an expert panel and/or tested by an EU re..

The EU Regulations on medical devices and in vitro diagnostic medical devices MDR, IVDR1. Extension of MDR transitional period    - 31 Dec 2027: class III, class IIb implantable    - 31 Dec 2028: Other class IIb, class IIa, class I m/s 2. Extension of IVDR transitional period    - 31 Dec 2027: devices covered by IVDD certificate and class D    - 31 Dec 2028: class C     - 31 Dec 2029: class B, c..

1. Introduction Article 120 of the Medical Device Regulation (EU) 2017/745 (MDR), as amended by Regulation (EU) 2023/607, states that devices which are covered by valid certificates issued by a notified body under the Active Implantable Medical Devices Directive 90/385/EEC (AIMDD) or the Medical Devices Directive 93/42/EEC (MDD) may be placed on the market or put into service after the date of a..