Europe – Experts outline challenges of combination products in Europe

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…