Global Regulatory Lead – Medical Device Regulatory Compliance Unit, Gedeon Richter Plc.
I graduated as a lawyer and previously worked for the Hungarian Medical Device Competent Authority for a long time. In addition to market surveillance of stand alone medical devices, my responsibilities included procedures related to the designation of notified bodies for conformity assessment. Then I decided to know thec” other” side, the perspective of a manufacturer and joined to Richter’s Medical Device Regulatory Compliance Unit. Combination products are a new world for me. The challenges are increased by the lower degree of regulation than in the case of stand-alone devices. Packaging material or device? Medicine or medical device? Which regulation applies to it? Which is the responsible authority? What if we want to distribute all this outside the European Union? There are many questions, much fewer answers, but it is nice to win from here.
