Document ID: chunk:federal_register_of_legislation:F2025C00024:clause:3_4:p2
Version: federal_register_of_legislation:F2025C00024
Segment Type: clause
Provision Reference: sch 3 cl 4 (pt 2/3)
Character Range: 6934–9969

means Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices, as in force on 1 December 2024.
EU medical devices regulation means Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, as in force immediately before the commencement of this instrument.

       generic device group has the same meaning as in the EU IVD regulation.
IAF accredited conformity assessment body means a body that is accredited to undertake certification for compliance with ISO 13485 by an accreditation body member that is a signatory to the Multilateral Recognition Arrangement of the International Accreditation Forum, Inc., otherwise known as the IAF MLA.
implantable medical device has the same meaning as in the Regulations.
in-house IVD medical device has the same meaning as in the Regulations.

       instructions for use has the same meaning as in the Regulations.
ISO 13485 means International Standard ISO 13485:2016 Medical devicesQuality management systemsRequirements for regulatory purposes, issued by the International Organization for Standardization in March 2016, as in force or existing immediately before the commencement of this instrument.

         Note: ISO 13485 is published at: https://www.iso.org.

       IVD companion diagnostic has the same meaning as in the Regulations.
IVD medical device, or in vitro diagnostic medical device, has the same meaning as in the Regulations.

       IVD medical device for self-testing has the same meaning as in the Regulations.
Japanese PMD Act means The Law on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices of Japan, as in force immediately before the commencement of this instrument.
manufacturing licence has the same meaning as in the Regulations.
MDSAP certificate means a certification document issued by a recognised auditing organisation following the completion of an audit of a manufacturer's quality management system.
measuring function has the same meaning as in the Regulations.
medical device used for a special purpose has the same meaning as in the Regulations.
NATA has the same meaning as in the Regulations.
notified body means a body that has been designated by a member state of the European Union, and notified to the European Commission, to assess the conformity of medical devices, including in vitro diagnostic medical devices and active implantable medical devices.

       point of care testing has the same meaning as in the Regulations.
quality management system certificate means a certificate that is issued following an assessment of a manufacturer's quality management system, but does not include a MDSAP certificate.
recognised auditing organisation means an organisation authorised to perform audits under the Medical Device Single Audit Program by the Regulatory Authority Council, in relation to that program, comprising the Australian Therapeutic Goods Administration, the