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 Performance Requirements (GSPRs) as outlined in MDR’s Annex I.
In the absence of any guidance document on the dossier format and content for the fulfillment of the GSPRs especially for single integral drug-device combinations, the EBE DDC topic group has developed the following case study to provide industry’s position on how to prove the fulfillment of the GSPRs.
In particular, the case study assesses the target product of a drug prefilled pen which is composed of an auto-injector and a drug prefilled syringe and gives an example of a GSPR checklist.
Each GSPR was assessed for applicability to the defined single integral drug-device combination, applicable method of conformity as well as how industry anticipates demonstrating evidence of conformity with the given GSPR. Special attention was given to the fact that certain GSPRs are superseded by medicinal product requirements that are governing the DDC. Another subset was excluded based on the given technology of the target product or considered only partially applicable where justified. Recent positions published by EBE and EFPIA to overall topics such as labeling or clinical requirements were considered and incorporated. Furthermore, acknowledging different approaches and styles are used across companies, the case study and used terms were developed in a generic manner to allow flexibility but to serve for a general understanding.
Main challenges as well as considerations expressed during the development of the case study are highlighted in the preamble section and should open up further discussion as needed.
With the publishing of that Industry case study, there is a strong desire to increase the exchange on that topic, clarify outstanding questions as well as to give the relevant stakeholders the opportunity in commenting on industry’s position.
Read the full position paper here.