The Regulatory Roadmap for the European Registration of Nanotechnology-Based Medical Devices and IVDs is Published by MARACA International for the Safenmt Consortium
Dr. Luc Van Hove develop an introduction report to the regulatory roadmap for the European registration of nanotechnology-based medical devices and IVDs.
This regulatory roadmap is the same for conventional medical devices and IVDs as for nanotechnology-based medical devices or IVDs. However, for the latter additional analytical performance characterization, risk management and labeling is required. This 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.
The next two weeks two Safenmt trainings will be organized.
The first external presentation 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.