Combination products are increasingly important, increasingly complex and are increasing the pressure on the European regulatory network, according to Thomas Wejs Møller, senior director for regulatory affairs – devices at Novo Nordisk.
Article 117 of the EU Medical Device Regulation (MDR) and notified body opinions were key among the challenges discussed by Møller and colleagues during a panel discussion at the 2024 Combination Products in the EU Summit held jointly by DIA and the Regulatory Affairs Professionals Society (RAPS).
Article 117 requires a marketing authorization applicant or holder of an integral drug-device combination product (DDC) to get a notified body opinion (NBOp) that confirms the device portion is compliant with MDR’s general safety and performance requirements (GSPR). This is also the case when a company seeks to make a change to the device component of a product marketing under the old Medical Device Directive (MDD), Møller explained…
