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IVDR resources and downloads.

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In Vitro Diagnostic Device Regulation (IVDR) guide

This In Vitro Diagnostic Device Regulation (IVDR) guide will give you an overview of the key areas of focus and changes within the regulation.

Brochure
Medical
Healthcare & Medical
BA Certification

Guide to IVDR conformity assessment procedures

Manufacturers looking to launch their in vitro diagnostic device (IVD) within the European Union need to comply with the relevant EU in vitro diagnostic device regulations.

Brochure
Medical
Healthcare & Medical
BA Certification

How to classify your IVD

This guide will help you classify your in vitro diagnostic device - an important first step for manufacturers who are getting their devices into the European market.

Brochure
Medical
Healthcare & Medical
BA Certification
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