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EU IVDR & MDR

6-Part Series

EU IVDR & MDR

This series explores how the EU In Vitro Diagnostic Regulation (IVDR) and Medical Device Regulation (MDR) impacts the clinical lab industry, including what labs and manufacturers must do to ensure compliance.

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Articles in this Series

Photo of a document folder with the word “IVDR” on it in bold red letters and other office supplies on a desk.

EU IVDR 2017/746: Impact to Clinical Laboratories and Drug Developers

EU IVDR 2017/746: Impact to Clinical Laboratories and Drug Developers

Map of the The IVDR applies to the 27 countries of the European Union, as well as the four countries of the European Free Trade Association States.

What is IVDR? How Can You Ensure Your Lab Complies with It?

What is IVDR? How Can You Ensure Your Lab Complies with It?

MDCG guidance documents help interpret classification rules for EU MDR and IVDR

How to Classify Medical and Diagnostic Devices for European Markets

How to Classify Medical and Diagnostic Devices for European Markets

Man in white jumpsuit wearing goggles and black lanyard reads laptop while crossing an engineering lab floor

The Impact of New Regulations on IVD Manufacturing

The Impact of New Regulations on IVD Manufacturing

example of an in vitro diagnostic medical device

IVDR: The EU’s In Vitro Diagnostic Regulation for Medical Diagnostic Tests

IVDR: The EU’s In Vitro Diagnostic Regulation for Medical Diagnostic Tests

IVDR—The Impact of COVID-19

IVDR—The Impact of COVID-19

IVDR—The Impact of COVID-19

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