What is the webinar about?
The Regulation on in vitro diagnostic medical devices (EU) 2017/746 introduced updated and expanded definitions that reflect changes in technology, progress in diagnostics, and improvements in regulatory oversight. One key definition is Definition 11 in Article 2: "’kit’ means a set of components that are packaged together and intended to be used to perform a specific in vitro diagnostic examination, or a part thereof”. Besides a clear definition, the Regulation has not reserved a dedicated clause to the regulatory requirements applicable to IVD kits in a similar fashion as to the medical device procedure pack counterpart in (EU) 2017/745.
Participants will gain understanding of the following:
- Definitions of IVD Kits, accessories, components and procedure packs
- Qualification and classification of IVD kits, components and accessories
- Regulatory requirements for IVD kits, components and accessories
- Product configurations and potential certification scenarios
- Market placement of IVD kits, components and accessories
Who should attend?
This webinar will be relevant for IVD manufacturers, distributors and importers.
Register now for one of two sessions on Tuesday 10 September 2024:
09:00 BST - Register here
16:00 BST - Register here
Speakers
To find out more about IVDR and the extension to the IVDR transition timeline, visit our dedicated IVD webpage and follow us on LinkedIn at BSI In Vitro Diagnostics Regulatory Services.
Email: medicaldevices@bsigroup.com
Phone: +44 3450809000
