The EU IVDR holds manufacturers of in vitro diagnostic devices (IVDs) to a higher standard. Conformity assessment requirements of IVDR specify that manufacturers must provide, among other things, considerable evidence of scientific validity, as well as data demonstrating analytical and clinical performance of the devices.
Because of this, there are also implications for users of IVDs, and significant requirements for labs who develop and run their own “in-house devices” as part of workflows intended for clinical use.
Users of laboratory-developed tests (LDTs) who wish to continue to do so beyond the May 2028 deadline will be required to prove that their home-brew test(s) fulfil Article 5(5) requirements, which briefly state:
- Experience from clinical use regularly reviewed and corrective action taken if necessary
- Information (including justification of manufacture, modification and use) is available on request to the competent authority
- Specific needs of the target patient group cannot be met to an appropriate level of performance by a commercially available CE-IVD
- Device cannot be made on an industrial scale, or transferred outside of the health institution
- Device manufacture/use occurs under an appropriate Quality Management System
- Device meets general safety and performance requirements set out in Annex I
- Laboratory is compliant with ISO:15189 (or equivalent) standard
To summarise, if a laboratory intends to continue using their own LDT, they adopt the role of a manufacturer and must undertake the onerous task of compiling the relevant data.
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