New IVDR regulation explained for developers of in-vitro diagnostic medical devices

During the 24 November group meeting of the COOCK project ‘Medical diagnostics goes micro and smart‘, in which MEDVIA is collaborating with Sirris, a seminar will be organized by one of the member companies. This part of the meeting will therefore be open to third parties and companies not involved in the project.

Qarad, part of the QbD group, is specialized in Regulatory Affairs and Quality Systems for the IVD industry and will tell us more about the new IVDR regulation. This regulation concerns placing in-vitro diagnostic medical devices and accessories on the EU market. The regulation also applies to performance studies conducted in the EU around such devices.

The term ‘in-vitro diagnostic medical device’ covers any medical device that is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination with another device. The device is intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information on, make predictions of or monitor the condition and responses of the human body.

During this seminar on 24 November from 11.00-13.00, we will focus on the application of the regulation on microfluidic chips and on their conditioning and read-out devices meant for diagnostic testing.

For whom?

The seminar is aimed at companies manufacturing the systems and accessories for such in-vitro diagnostic medical devices, including their suppliers and service providers.

Participant fee

The seminar is free for members of the supervisory group of the COOCK project ‘Medical diagnostics goes micro and smart‘. Other participants pay €200 (excluding VAT).

To register, visit the Sirris website.

8 November 2022
Written by Lisa Bradshaw