Applicability of the European Medical Devices Regulation to pre-filled glass syringes. Case study of the registration of a vaccine in Europe.

Laura BERARDI; Daniel MARTINEZ; Andrea SALMASO

doi:10.11347/pda.27.1

Topics Review

Applicability of the European Medical Devices Regulation to pre-filled glass syringes. Case study of the registration of a vaccine in Europe.

Laura BERARDI, Daniel MARTINEZ, Andrea SALMASO

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Keywords: Medical Device Regulation Annex 1, Combination Product Registration, Medical Device Registration, Requirement Checklist for PFS Registration, European Regulatory Requirements, Notified Body Requirements

JOURNAL FREE ACCESS

2025 Volume 27 Issue 1 Pages 1-13

DOI https://doi.org/10.11347/pda.27.1

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Abstract

This article is based on a case study for obtaining the Notified Body Opinion of a staked needle glass syringe pre-filled with a vaccine, produced by an Asian pharmaceutical industry and registered in Europe.

We will follow step by step the filing of the technical dossier, which documents to request from suppliers and which information to provide to the Notified Body.

This document will be a useful guide for the applicant to reduce the time and costs of applying a device constituent of a combined product according to the Art.117 of EU 2017/745.

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