Dr. Allan Goldman:

If no CE-marked device is available, the HPRA process allows for people to approach it about innovation. It would work with the person and a company to try to develop a new product. It assesses the product, including whether it is medical grade, and goes through all those processes. If it is a new device there are parallel processes: one is research ethics, the other is about getting the device approved. One cannot just take a non-CE marked, non-medical grade device and suddenly decide it will be part of the process.