Webinar
Medical Devices

Understanding and meeting the EU IVDR requirements for IVD Kits

In vitro diagnostic medical devices (EU) 2017/746 definitions that reflect changes in technology, progress in diagnostics and regulatory oversight.

Watch the Webinar View the Presentation

Definitions of IVD Kits, accessories, components and procedure packs.

This webinar will be relevant for IVD manufacturers, distributors and importers.

Market placement of IVD kits, components and accessories.
Qualification and classification of IVD kits, components and accessories.
Regulatory requirements for IVD kits, components and accessories.
Product configurations and potential certification scenarios.

Speakers

Hear from these experts in this webinar

Speaker

Alex Laan

Head of IVD Notified Body, BSI.

Speaker

Sara Fabi

Regulatory Lead, IVDR, BSI.

Insights & Media

Find out about the latest quality trends with insights from our experts

Get Insights & Media

Ageing Population: A Catalyst for Healthcare Innovation

Lees de blog

Symbols & Details Required for Medical Devices & IVDs

Lees het whitepaper

Using Standards to Demonstrate Conformity

Lees het whitepaper

Annex XVI - Devices Without an Intended Medical Purpose

Lees het whitepaper

EU MDR – Post Market Clinical Follow-Up

Lees het whitepaper

Medical Device Lifetime - Assisting manufacturers

Lees het whitepaper

Contact opnemen

Samenwerken aan de toekomst van uw organisatie

Neem contact met ons op en ontdek hoe wij u kunnen helpen met het realiseren van duurzame groei en succes.

Contact opnemen

Contact opnemen