The transition from the previous European Union In vitro Diagnostic Directive (IVDD) to the In Vitro Diagnostic Regulation (IVDR) is a challenging process for manufacturers.

It introduces risk-class based devices, requires compliance with more rigorous documentation, clinical evidence, and post-market surveillance requirements, ultimately to ensure the safety, effectiveness, and reliability of IVDs.

This webinar aims to provide an overview to manufacturers of Key Changes from IVDD to IVDR, conformity assessment process and SGS Belgium NV NB1639 services to help them with the necessary information to ensure their devices are put on the market and are compliant to the higher standards set by the IVDR.

AGENDA

EU IVDR 2017/746 Regulation Overview
Does my device fall under the IVDR?
Key Changes from IVDD to IVDR: Quality Management Systems (QMS) and Technical Documentation
Conformity Assessment Procedure
SGS Belgium NV NB1639: how we can help

WHO SHOULD ATTEND?

In vitro diagnostic medical devices manufacturers – globally, including corporations and SMEs, start-ups

Person Responsible for Regulatory Compliance (PRRC)
EU Authorized Representatives
Regulatory affairs managers and their team
Quality managers and their team
Technical directors and their team
R&D Managers and their team
Validation Managers and their team

Language: English

Cost: No Charge

Speakers

IVDR Product Assessor

Elaine

O’Neil

Elaine O'Neill is an IVDR product assessor with SGS. She has a degree in Biomedical Sciences, and a PhD in Pathophysiology. She has worked in the IVD industry for 13 years including 9.5 years within R&D and 3.5 years in consultancy capacity.

IVDR Product Assessor

Davide

Rigamonti

Biotechnologist with broad experience in production, quality control, design & development and regulatory in IVD business. Product assessor in SGS with solid experience in molecular biology, different technologies and devices.