Document ID: chunk:federal_register_of_legislation:F2025C00021:front:0:p9
Version: federal_register_of_legislation:F2025C00021
Segment Type: other
Provision Reference: 
Character Range: 24837–27914

progression of a disease or condition etc.
4.7 Programmed or programmable medical device or software that is a medical device for use in specifying or recommending treatment or intervention
4.8 Programmed or programmable medical device or software that is a medical device that is to provide therapy to a person through the provision of information
Part 5—Special rules for particular kinds of medical devices
5.1 Medical devices incorporating a medicine
5.2 Medical devices intended for contraception or prevention of sexually transmitted diseases
5.3 Medical devices intended for disinfecting, cleaning, etc
5.4 Medical devices that record patient images or that are anatomical models etc.
5.5 Medical devices containing non‑viable animal tissues, cells or their derivatives
5.6 Medical devices that are blood bags
5.7 Active implantable medical devices
5.8 Medical devices intended for export only
5.9 Medical devices that are mammary implants
5.10 Medical devices that administer medicines or biologicals by inhalation
5.11 Medical devices that are substances to be introduced into the body or applied to and absorbed by the skin
Schedule 2A—Classification rules for IVD medical devices
1.1 Detection of transmissible agents posing high public health risk
1.2 Detection of red blood cell antigens and antibodies and non‑red cell typing
1.3 Detection of transmissible agents or biological characteristics posing moderate public health risk or high personal risk
1.4 IVD medical devices for self‑testing
1.5 Non assay‑specific quality control material
1.6 Reagents, instruments etc
1.7 Other IVD medical devices are Class 2 IVD medical devices
1.8 IVD medical devices intended for export only
Schedule 3—Conformity assessment procedures
Part 1—Full quality assurance procedures
1.1 Overview
1.2 References to kinds of medical devices
1.3 Implementation and assessment of quality management system
1.4 Requirements of quality management system
1.5 Changes to quality management system or kinds of medical device to which system is to be applied
1.6 Examination of design of Class 4 IVD medical device, Class 4 in‑house IVD medical device or Class III medical device
1.7 Information to be given to authorised person
1.8 Declaration of conformity
1.9 Records
Part 2—Type examination procedures
2.1 Overview
2.2 References to kinds of medical devices
2.3 Examination of type
2.4 Changes to design of medical device after examination
2.5 Records
Part 3—Verification procedures
3.1 Overview
3.2 References to kinds of medical devices
3.3 Verification of conformity
3.4 Requirements of manufacturing system
3.5 Declaration of conformity
3.6 Records
Part 4—Production quality assurance procedures
4.1 Overview
4.2 References to kinds of medical devices
4.3 Implementation and assessment of production quality management system
4.4 Requirements of production quality management system
4.5 Changes to production quality management system
4.6 Information to be given to authorised person
4.7 Declaration of conformity
4.8 Records
Part 5—Product quality assurance procedures
5.1 Overview