Requirements for the Development and Use of in-house In Vitro Diagnostic Devices (IVDs)
An Australian national pathology accreditation standard on developing and using in-house IVDs. The device regulations require laboratories that make in-house IVDs to meet it.
Whether the market recognizes, harmonizes or adopts this standard, and which edition it accepts
| Market | Status | Edition accepted | National code | Details |
|---|---|---|---|---|
| Australia | Referenced | - | - | Named in the medical device regulations. Laboratories that make in-house IVDs must meet it. |
Open the market page and its pathway pages for the full requirement, protocol and report content
Related standards: CLSI EP06, CLSI EP07, CLSI EP09c, CLSI EP12, CLSI EP19, CLSI EP21, CLSI EP25, CLSI EP35, ISO 17511, ISO 20916, CLSI EP05, CLSI EP14. See .
Not legal or regulatory advice. Check the current official rules before you act. Parts of the approvals data are official open data reused under open licences. Data sources.