Dr. Luc Van Hove of MARACA International developed a regulatory roadmap for NT-based MD.
Luc developed a regulatory roadmap for the EU registration of Nanotechnology (NT)-based medical devices (MD) and IVDs. This roadmap was commissioned by the Safenmt consortium. For NT-based MD and IVD, as for conventional MD and IVD, this regulatory roadmap is the same. However, for the NT-based MD additional analytical performance characterization, risk management and labeling is required. The report is now used for training of Safenmt consortium partners and will be presented externally at nanotechnology scientific meetings.
The objective is to educate the nanotechnology field on the required steps for developing a nanotechnology-based medical device and IVD in compliance with the MDR and IVDR regulations.
Within the next two weeks two Safenmt trainings will be organized.
A first external presentation of the regulatory roadmap for NT-based MD will be at the NanoMedSpain symposium on 20 May 2021, which has the new MDR as symposium topic.
Another session is planned for the ETPN (Nanomedicine European Technology Platform) conference on 7-9 September 2021 in Switzerland.