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The In Vitro Diagnostic Medical Device Regulation

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The In Vitro Diagnostic Medical Device Regulation

The IVDR is the current regulatory basis for placing on the market, making available and putting into service in vitro diagnostic medical devices on the European market. It was published in the Official Journal of the EU on 5 May 2017, and entered into force on 26 May 2017, gradually replacing the EU’s former Directive on in vitro diagnostic medical devices (98/79/EC). 

The IVDR differs in several important ways from the EU’s previous directive on in vitro diagnostic medical devices. In addition, following the publication of Regulation (EU) 2022/112 of the European Parliament and of the Council of 25 January 2022, the transition period depends on the class of the IVD device under the current Directive and future Regulation as well as additional conditions.

The infographic below illustrates the key changes, timeline, step-by-step guide to IVDR certification, as well as a brief look into TÜV SÜD's medical device testing service which is completely independent from the Notified Body.

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IN VITRO DIAGNOSTIC MEDICAL DEVICE TESTING SERVICES

At TÜV SÜD, we offer a comprehensive solution for IVD medical device testing. We offer expert knowledge and global network of accredited laboratories and facilities at TÜV SÜD. Our testing services cover the entire product design and production cycle, ranging from prototype testing to CB certification and lab tests for ergonomics, electrical, mechanical and functional safety assessments, as well as software testing.

Additionally, we conduct production facility inspections, environmental monitoring, and pre-shipment inspections. Our testing services are not limited to active medical devices but also encompass non-active medical devices and IVDs. With our comprehensive medical devices industry assessment, we can help you ensure compliance with global standards and regulations. Read below to find out more about our IVD test standards.

Click here to find out more about our IVD testing services

 

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RELATED INFORMATION

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IVDR Request for Service Registration

Be confident of IVD medical device market approval

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