RegN - Regulatory plan for NanoEcho

Purpose and goal:

The focus of the project was to develop a regulatory strategy and plan for NanoEcho´s system, including both magnetomotor ultrasound, including probe and software, aswell as the iron oxide-based nanoparticle, which acts as a contrast agent. The purpose was to get support for regulatory categorization of the entire system and based on that to identify laws and regulations that apply to obtain market approval, and as next step to identify necessary activities.

Expected results and effects:

The device is classified as a medical device, class IIA, according to EU MDR 2017/745 and the nano particle is classified as a medical product according to DIRECTIVE 2001/83/EC. Much of the documentation required for the nanoparticle is already compiled, as the nanoparticle is used today for another medical indications. We are currently working on defining the gap, the specific activities required for NanoEcho to get approval to start the clinical study required for market approval.

Approach and implementation:

As the regulatory classification of the nanoparticle, which is developed and manufactured externally, was in the borderland between medical technology and pharmaceuticals, specialist expertise was required to sort out 1) which laws to follow 2) which activities to be performed to obtain regulatory approval to start a clinical trial for market approval, as well as to identify what has already been done and what NanoEcho needs to do. Two regulatory experts were engaged: one in medical technology for stage 1 and a pharmaceutical expert for stages 2 and 3.