PDA Europe Webinar - The Medical Device Regulation - Stevanato Group
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PDA Europe Webinar - The Medical Device Regulation - Stevanato Group
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WEBINAR

PDA Europe Webinar - The Medical Device Regulation

19 November 2020

Learn more about the new regulation on medical devices EU 2017/745 by joining this PDA’s webinar!

This webinar will give more insights into the definition of the Drug Device Combination Products (DDCs) in the EU, going into detail about quality and regulatory requirements.

PDA Webinar Regulatory 2020 Banner
PDA Webinar Regulatory 2020 Banner

Webinar details:

  • Date: Thursday, November 19th
  • Time: 4.00 pm - 5.30 pm (CET)
  • Duration: 1.30 h

Webinar Abstract

The new regulation on medical devices EU 2017/745 has provided a more detailed definition of the Drug Device Combination Products (DDCs) in the EU, also covering quality and regulatory requirements.
For integrated DDCs intended to administer a medicinal product, article 117 also amends the Directive 2001/83/EC, requiring the applicant to include the results of the assessment of the conformity of the device constituent with the relevant General Safety and Performance Requirements (GSPR) in the marketing authorization dossier.

These changes have increased the discussion among the container closure system manufacturers, as it seems not fully clear how a sub-assembled device can be demonstrated to fulfill regulatory expectations. This PDA Webinar, therefore, aims to address relevant industry stakeholders interested in collaborating on a Technical Report document to support component manufacturers in providing the applicant with the appropriate information on device conformity with the relevant GSPR.

The discussion will involve industry representatives as well as provide Notified Body Opinion.

Agenda

Introduction

Andrea Salmaso, Stevanato Group

PFS and Combination Products Design and Development

Fabrizio Bacelle, Stevanato Group

Technical, Quality and Safety Information Requirements in Annex I Applicable for Prefilled Syringes and Major Implications

Ankica Jakovljevic, Stevanato Group

Notified Body Opinion

Simone Antonini, TÜV Rheinland

PDA Technical Report Proposal

Andrea Salmaso, Stevanato Group

Interactive Live Q&A and Discussion

Join the webinar!

Get more information about Stevanato Group's Regulatory Support by clicking here.