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EBE-EFPIA Position Paper: An Industry Perspective on Article 117 of the EU Medical Device Regulation: Labelling Requirements for Prefilled, Non-Reusable, Integral Drug-Delivery Device Combination Products
Prefilled, non-reusable, integral drug-device combinations (DDCs) are regulated as medicinal products, if the intention is to administer the medicinal product to the patient. However, the device component needs to conform with “relevant” General Safety and Performance Requirements set out in Annex I of the Medical Device Regulation (MDR, Regulation (EU) 2017/745). It is EBE and EFPIA’s