For the EU:
IVD's that are placed on the market must comply with the IVD directive and carry the CE mark. An RUO by definition is intended for research use only, not clinical use and therefore does not meet the requirements of the directive.
If you want to add an RUO kit to IVD equipment and use it in a clinical setting then it must comply with the directive.
For USA, you can follow recommendations HERE. I am not sure if you would require Registration/Listing though. Any comments about registration/listing requirements, Exempt or Subject to Enforcement Discretion?
In practice, RUOs are used in laboratories for diagnostics. However, the laboratories then validate each RUO batch and associated procedures prior to use (Europe).
In practice, RUOs are used in laboratories for diagnostics. However, the laboratories then validate each RUO batch and associated procedures prior to use (Europe).
This is true but under Regulation EU 2017/746 (IVDR), this will need to be covered through a Health Institution Exemption, where the conditions (Art. 5 (5)) can be met. This will mean a lot of changes are required from May 2022 to demonstrate conformity of each RUO that is used for a diagnostic purpose.
For USA, you can follow recommendations HERE. I am not sure if you would require Registration/Listing though. Any comments about registration/listing requirements, Exempt or Subject to Enforcement Discretion?
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