Regulatory Open Forum

During the trial, we intend to introduce a new pen system to replace the syringes and needles. The new pen system is a non-integral drug-device combination product that includes BWFI cartridges and a single-use reconstitution device to be used together with the multidose vials of our IMP. Commercially available needles for the pen injector and a reusable injection pen are used for the administration of the reconstituted drug.

The medicinal product, the reconstitution device and the BWFI cartridge will be packaged together in the same pack. However, the reusable pen injector will be packaged separately. 

The injection pen and the reconstitution device are both class IIb, non-invasive devices; however, both device components are not currently commercialized in Europe and therefore do not have a CE mark.

• Is it possible to introduce a new injection pen system during the clinical trial via a substantial amendment to the study protocol, IMPD and IB?
• Would Member State competent authorities expect a separate clinical investigation of the device components to have been completed prior to including them in the proposed clinical trial?
• It is my understanding that the requirement for a CE mark for a device is strictly for commercial purposes and therefore the device/device components in the context of a clinical trial do not require a CE mark. Is this interpretation correct?

During the trial, we intend to introduce a new pen system to replace the syringes and needles. The new pen system is a non-integral drug-device combination product that includes BWFI cartridges and a single-use reconstitution device to be used together with the multidose vials of our IMP. Commercially available needles for the pen injector and a reusable injection pen are used for the administration of the reconstituted drug.

The medicinal product, the reconstitution device and the BWFI cartridge will be packaged together in the same pack. However, the reusable pen injector will be packaged separately. 

The injection pen and the reconstitution device are both class IIb, non-invasive devices; however, both device components are not currently commercialized in Europe and therefore do not have a CE mark.

• Is it possible to introduce a new injection pen system during the clinical trial via a substantial amendment to the study protocol, IMPD and IB?
• Would Member State competent authorities expect a separate clinical investigation of the device components to have been completed prior to including them in the proposed clinical trial?
• It is my understanding that the requirement for a CE mark for a device is strictly for commercial purposes and therefore the device/device components in the context of a clinical trial do not require a CE mark. Is this interpretation correct?

During the trial, we intend to introduce a new pen system to replace the syringes and needles. The new pen system is a non-integral drug-device combination product that includes BWFI cartridges and a single-use reconstitution device to be used together with the multidose vials of our IMP. Commercially available needles for the pen injector and a reusable injection pen are used for the administration of the reconstituted drug.

The medicinal product, the reconstitution device and the BWFI cartridge will be packaged together in the same pack. However, the reusable pen injector will be packaged separately. 

The injection pen and the reconstitution device are both class IIb, non-invasive devices; however, both device components are not currently commercialized in Europe and therefore do not have a CE mark.

• Is it possible to introduce a new injection pen system during the clinical trial via a substantial amendment to the study protocol, IMPD and IB?
• Would Member State competent authorities expect a separate clinical investigation of the device components to have been completed prior to including them in the proposed clinical trial?
• It is my understanding that the requirement for a CE mark for a device is strictly for commercial purposes and therefore the device/device components in the context of a clinical trial do not require a CE mark. Is this interpretation correct?

During the trial, we intend to introduce a new pen system to replace the syringes and needles. The new pen system is a non-integral drug-device combination product that includes BWFI cartridges and a single-use reconstitution device to be used together with the multidose vials of our IMP. Commercially available needles for the pen injector and a reusable injection pen are used for the administration of the reconstituted drug.

The medicinal product, the reconstitution device and the BWFI cartridge will be packaged together in the same pack. However, the reusable pen injector will be packaged separately. 

The injection pen and the reconstitution device are both class IIb, non-invasive devices; however, both device components are not currently commercialized in Europe and therefore do not have a CE mark.

• Is it possible to introduce a new injection pen system during the clinical trial via a substantial amendment to the study protocol, IMPD and IB?
• Would Member State competent authorities expect a separate clinical investigation of the device components to have been completed prior to including them in the proposed clinical trial?
• It is my understanding that the requirement for a CE mark for a device is strictly for commercial purposes and therefore the device/device components in the context of a clinical trial do not require a CE mark. Is this interpretation correct?

During the trial, we intend to introduce a new pen system to replace the syringes and needles. The new pen system is a non-integral drug-device combination product that includes BWFI cartridges and a single-use reconstitution device to be used together with the multidose vials of our IMP. Commercially available needles for the pen injector and a reusable injection pen are used for the administration of the reconstituted drug.

The medicinal product, the reconstitution device and the BWFI cartridge will be packaged together in the same pack. However, the reusable pen injector will be packaged separately. 

The injection pen and the reconstitution device are both class IIb, non-invasive devices; however, both device components are not currently commercialized in Europe and therefore do not have a CE mark.

• Is it possible to introduce a new injection pen system during the clinical trial via a substantial amendment to the study protocol, IMPD and IB?
• Would Member State competent authorities expect a separate clinical investigation of the device components to have been completed prior to including them in the proposed clinical trial?
• It is my understanding that the requirement for a CE mark for a device is strictly for commercial purposes and therefore the device/device components in the context of a clinical trial do not require a CE mark. Is this interpretation correct?