Europe – Expert: Combination product firms need EU guidance amid regulatory ambiguity

The EU Medical Device Regulation (MDR) created confusion for medical device manufacturers in Europe, including drug-device combination (DDC) producers. As stakeholders seek more guidance from regulators, one expert said that clarity needs to come from the European Commission (EC) and the planned revision to the EU pharmaceutical legislation.

Timothy Chesworth, a senior director of regulatory affairs at AstraZeneca, spoke about MDR and how it has created confusion for combination product developers at the Combination Products Summit 2022 hosted by the Regulatory Affairs Professionals Society (RAPS) and the Association of Food and Drug Officials (AFDO). He honed in on Article 117 of MDR, which amends the medicinal product directive, and a Q&A guidance issued by the European Medicines Agency (EMA) on combination products.

The guidance notes that while Article 117 does not apply retrospectively to DDCs that are already authorized in the EU or to products with Marketing Authorization Applications (MAA) submitted before 26 May 2021, there are conditions when a change to the product may require a new notified body opinion (NBO) or a conformity assessment. Those conditions include changes to the design or intended purpose of the device, changes to the primary function, changes to the operating principles and changes to the route of administration…