AH7 – Regulatory on Medical Devices

The HYPOSENS system comprises two entities: the temperature and oxygen sensor components in a tumour-targeted dual sensing biocompatible nanocapsule, and the external photonic ratiometric sensing device. The injected nanocapsules are medicinal products subject to the requirements of EU Directive 2001/83 Community code relating to medicinal products for human use. They are also in scope of EC Regulation 726/2004/EC Annex I, so will require Community authorisation of the marketing application i.e. application will be made to the European Medicines Agency for marketing authorisation under the centralised procedure.

The photonic sensing device and the incorporated processing software qualify as a medical device under Article 2 of the Medical Device Regulation (MDR) 2017/745. The product must comply with the applicable General Safety and Performance Requirements. Following conformity assessment of the technical documentation by a notified body, the CE mark (Conformité Européene) may be affixed to the product, and it may be placed on the market in any of the EU Member States.

The regulatory requirements of the Directive and Regulations above have been taken into consideration throughout the HYPOSENS project, to facilitate ultimate regulatory authorisation of the system and its subsequent marketing.