Regulatory Open Forum

You didn't say whether the question is about the IVDD or the IVDR so I infer it is the IVDR.

Does the EU require the Rx Only symbol on IVD labeling?
Article 1(9) says, "This Regulation shall not affect national law concerning the organization, delivery, or financing of health services and medical care, such as the requirement that certain devices may only be supplied on a medical prescription, the requirement that only certain health professionals, or health care institutions may dispense or use certain devices or that their use be accompanied by specific professional counselling".

The Rx Only symbol in the US restricts sales. In the EU, this is at the Member State level, not the Union level. You will need to determine any requirements from each Member State.

The traditional sources of symbols (EN ISO 15223-1:2016, Use of Symbols to Indicate Compliance with the MDR – December 2019, and IVDR – MDR Labelling differences: what symbols apply to IVDs – November 2019) don't have a symbol for Rx or OTC. Under Annex I(20.1)(h), because the IVDR doesn't have any harmonized standard or CS, "the symbols and colors shall be described in the documentation supplied with the device".

Are kit contents required to be on the kit box?
Annex I(20.2)(t) says the following information must be on the label, "the devices and separate components shall be identified, where applicable in terms of batches, to allow all appropriate action to detect any potential risk posed by the devices and detachable components. As far as practicable and appropriate, the information shall be set out on the device itself and/or, where appropriate, on the sales packaging".

Is the test required to be in one of the national languages of the country the kit is sold?
I infer "the test" means the instructions to run the test. They would be in the IFU under Annex I(20.4)(v), "assay procedure including calculations and interpretation of results and where relevant if any confirmatory testing shall be considered; where applicable, the instructions for use shall be accompanied by information regarding batch to batch variation provided with relevant figures and units of measure".

Article 10(10) says, "Manufacturers shall ensure that the device is accompanied by the information set out in Section 20 of Annex I in an official Union language(s) determined by the Member State in which the device is made available to the user or patient". This includes both eh label and the IFU.

You didn't say whether the question is about the IVDD or the IVDR so I infer it is the IVDR.

Does the EU require the Rx Only symbol on IVD labeling?
Article 1(9) says, "This Regulation shall not affect national law concerning the organization, delivery, or financing of health services and medical care, such as the requirement that certain devices may only be supplied on a medical prescription, the requirement that only certain health professionals, or health care institutions may dispense or use certain devices or that their use be accompanied by specific professional counselling".

The Rx Only symbol in the US restricts sales. In the EU, this is at the Member State level, not the Union level. You will need to determine any requirements from each Member State.

The traditional sources of symbols (EN ISO 15223-1:2016, Use of Symbols to Indicate Compliance with the MDR – December 2019, and IVDR – MDR Labelling differences: what symbols apply to IVDs – November 2019) don't have a symbol for Rx or OTC. Under Annex I(20.1)(h), because the IVDR doesn't have any harmonized standard or CS, "the symbols and colors shall be described in the documentation supplied with the device".

Are kit contents required to be on the kit box?
Annex I(20.2)(t) says the following information must be on the label, "the devices and separate components shall be identified, where applicable in terms of batches, to allow all appropriate action to detect any potential risk posed by the devices and detachable components. As far as practicable and appropriate, the information shall be set out on the device itself and/or, where appropriate, on the sales packaging".

Is the test required to be in one of the national languages of the country the kit is sold?
I infer "the test" means the instructions to run the test. They would be in the IFU under Annex I(20.4)(v), "assay procedure including calculations and interpretation of results and where relevant if any confirmatory testing shall be considered; where applicable, the instructions for use shall be accompanied by information regarding batch to batch variation provided with relevant figures and units of measure".

Article 10(10) says, "Manufacturers shall ensure that the device is accompanied by the information set out in Section 20 of Annex I in an official Union language(s) determined by the Member State in which the device is made available to the user or patient". This includes both eh label and the IFU.