Aclinical investigation may not be mandatory for Implantable and Class III medical devices under Article 61(4)-(6) of the European Union Medical Device Regulation (EU MDR) if one of four cases apply to the device under evaluation, said John Thomas, director of program delivery of MedTech at Premier Research.
With the EU MDR becoming fully applicable to all medical devices in Europe from 27 May, the new regulations were at the centre of talks at the Outsourcing in Clinical Trials: Medical Devices Europe 2024 conference in Munich, Germany on 30-31 January.
