In Vitro Diagnostic Medical Device Regulation Resources

Be confident of IVD medical device market approval

Be confident of IVD medical device market approval

ensure a smooth process while complying with the EU in vitro DIAGNOSTIC medical device regulation (IVDR)

The complex development process for in vitro diagnostic medical devices combined with the anticipated changes, can make the transition a complicated and time-consuming process for most device manufacturers.  

The resources below provide information and checklists to prepare you for EU's IVDR. Download these resources to ensure the latest information and guidance in your IVDR journey.

Resources

IVDR CDx
Bilgi Kitapçığı

IVDR Companion Diagnostics (CDx)

Download the brochure to learn how to successfully complete the CDx IVDR certification

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in vitro diagnostic infographic
İnfografik

The In Vitro Diagnostic Medical Device Regulation

Following the publication of regulation (EU) 2022/112, the IVDR will be rolled out gradually.

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Digital

IVDR QM System Requirements

See at a glance where IVDR requirements are fulfilled.

sampling

Sampling of Class B and C IVDR Devices

Sampling for Assessment of Technical Documentations according to IVDR Annex IX

IVDR Technical Documentation

IVDR Technical Documentation Submission Requirements

An overview on how to submit a Technical Documentation

Legacy Products Under IVDR

Legacy Products Under IVDR

What are the requirements for products that were already on the market under IVDD?

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