EU Regulation 2017/746 on In Vitro Diagnostic Medical Devices

Aspects and Requirements of the IVDR

On May 26, 2017, a new European regulation related to in vitro diagnostic medical devices entered into force. From May 26, 2022, both manufacturers of in vitro diagnostic devices and diagnostic providers will be subject to the In Vitro Diagnostic Medical Devices Regulation (IVDR) to access the European market. As an EU regulation, the IVDR has the force of law throughout the EU and eliminates country-by-country interpretations of the requirements permitted under directives.

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Topics covered in this report:

• Devices or services covered by the European Regulation
• Risk-based classification
• Conformity assessment procedures
• IVDR implementation timeline
• How you can prepare