In a typical drug development pathway, non-clinical studies are performed prior to clinical evaluation. Because nicotine uptake is dose dependent, regulators may request a non-clinical study prior to clinical evaluation of AYR+.
The hybrid application separates AYR+ into two entities: the device itself is the 'medicinal device' and the nicotine-containing capsule is the 'medicinal product'.
AYR+ will be considered a class IIa (medium risk) medical device. The classification of the medical device will have an impact on the conformity assessment route that the manufacturer will follow in order to affix the CE marking* on the medical device under the CE marketing scheme and will be controlled under the ISO 13485 quality management system. A CE Notified Body will verify the CE Declaration issued by the manufacturer. This Notified Body is accredited to validate the compliance of the device to the European Directive. An outline of the CE marking route for Class IIa medical devices is described in the schematic below.
*Also known as an EC (European Conformity) mark.
Similarly to the formulation batches, at least two devices will be tested for each study to reduce the inter- and intra-variability. Inter-variability is the performance between different devices and intra-variability is the performance on the same device. For example, in the case where one vaporiser is approximately equivalent to one cigarette and thus to one dose, it would be expected that the test is performed twice; once with the same vaporiser (and doses/charges from the same cartridge and refill/recharge case) (inter) and secondly with different vaporisers (and doses/charges from their respective (same) cartridge and refill/recharge case) (intra).
Ongoing collaboration between scientists and product developers at AYRlabs will determine all possible device failure scenarios and impact to product performance and ultimately, patient safety. This risk assessment will be a combination of paper exercise and analytical testing.
All materials used in the device will be traceable and quality systems are in place to flag up where the manufacturer alters any specification. Any changes to the device will be justified to ensure no performance impact or increased risk to the user. The device will be robust throughout its recommended use life to ensure consistent performance and dosing while minimising the chance of inconsistent dosing or accumulation of foreign particles that could be inhaled.