PDA Europe Webinar - The Medical Device Regulation: Guidance for Pre-filled Syringes and Combination Products

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Ask a Question Exhibitor Standard Contract Clause

Dear Colleagues, 

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, covering also 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 fulfil 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. 

We look forward to constructive collaboration and problem solving, and warmly invite you to join us! 

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WAYS TO REGISTER: 1. Online Registration   2. [email protected]

PDA MEMBERS: Please remember to log in before registering If you come from a Governmental or Health Authority Institution or from an Academic Organization, please contact [email protected] before registering.

If you need to apply for a visa to enter the event country, PDA Europe must be informed of this fact at least 4 weeks before the start of the event.

Day 1


Impact of the MDR on the Prefilled Syringes Market

Applicability of Standards and GSPR to the Device Constituent of Prefilled Syringes

Andrea Salmaso, Stevanato Group
PFS and Combination Products Design and Development

Design Control Ring Definition of the Device Constituent Part

Design Verification, Validation and Risk Management Challenges

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

Applicable Sections of Annex I

Expectations for Compatibility and Clinical Requirements

Ankica Jakovljevic, Stevanato Group
Notified Body Opinion
Drug-Device Combination Products: Regulatory Framework Under MDR Article 117
Simone Antonini, TÜV Rheinland
PDA Technical Report Proposal Andrea Salmaso, Stevanato Group
Interactive Live Q&A and Discussion
Agenda is subject to change.

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