France’s National Agency for the Safety of Medicines and Health Products (ANSM) will launch a pilot this fall on clinical investigations under the EU medical device regulation (MDR).
ANSM notes that MDR provisions relating to clinical investigations will result in new workflows among EU competent authorities and member states’ ethics committees. The first-of-its-kind pilot, to launch 16 September, will allow for the simulation of new working methods per MDR’s provisions “particularly with regard to the deadlines for the assessment of files and the organization of coordination.”
The pilot is intended to foster innovation, make the EU more attractive for industry to conduct research, facilitate patient access to treatments in the EU, as well as enhance the transparency around and access to data from clinical investigations, according to ANSM.
Clinical investigations of medium- to high-risk devices will be reviewed by expert panels in premarket clinical evaluation consultation procedures. ANSM’s pilot applies to class III implantable, class IIa or class IIb invasive devices, including those without CE marks and products without a medical purpose, across all therapeutic areas. Participation is voluntary.
While the European Commission (EC) faces mounting pressure to complete a range of implementing acts prior to the application of the new framework, a flyer last month offered a sneak peek into how expert panels will be established in support of MDR and the EU’s in vitro diagnostic regulation (IVDR). The EC’s factsheet to health care providers and institutions also recognized the potential for some devices to “become temporarily unavailable” because of MDR/IVDR.