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EBE-EFPIA Reflection Paper: Conformity with the relevant General Safety Performance Requirements listed in the European Medical Device Regulation 2017/745: Case study for a prefilled pen (prefilled syringe assembled with autoinjector parts forming a single integral product regulated as a medicinal product)
Article 117 of the Medical Device Regulation (EU) 2017/745 (MDR) requires the Marketing Authorization Applicant to include a Notified Body Opinion on the device constituent, part of a single integral Drug-Device Combination (DDC) in the Marketing Authorization Application, from 26 May 2020. With that, the applicant must demonstrate conformity with the relevant General Safety and