Medical Device Market Approval & Certification

In Vitro Diagnostic Regulation (IVDR)

Achieve EU market access for in vitro diagnostic medical devices.

Achieve EU market access for in vitro diagnostic medical devices.

What is the In Vitro Diagnostic Regulation (IVDR)?

The In Vitro Diagnostic Regulation (IVDR) is the current European Union (EU) regulatory legislation for placing in-vitro diagnostic devices on the EU market, making them available and putting them into service.

The IVDR regulation 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).

As a European regulation, it is effective in all EU member states and EFTA states immediately without needing to be transposed into the law of respective states. However, national laws may be adapted to back up some requirements in more detail.

Request for an IVDR Service Registration today

Download the IVDR Service Description

 

Key IVD amendments

Four additional regulations have been enacted with the primary purpose of providing adequate time and resources to ensure continued availability of devices on the EU market.

  Regulation

         Key Provisions

  (EU) 2022/112

  • First extension of transitional provisions for legacy devices
  • Introduction of staggered transition periods based on device classification

  (EU) 2023/503

  • Extension of the frequency of reassessment of notified bodies

  (EU) 2023/607

  • Removal of the sell-off period for devices placed on the market during the transition period

  (EU) 2024/1860

  • Second extension of transitional provisions
  • Addition of timelines for implementation of an IVDR-compliant quality system
  • Addition of timelines for application to and completion of a signed agreement with a notified body
  • Phased roll-out of the European Database on Medical Devices (EUDAMED)
  • Introduction of an obligation to notify an anticipated discontinuation of supply of devices

 

IVDR Transition Timeline

Only “legacy” devices meeting the following conditions can benefit from the IVDR transition timelines:

a) those devices continue to comply with Directive 98/79/EC;
b) there are no significant changes in the design and intended purpose;
c) the devices do not present an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health;

The transition period depends on the classification of the device and whether it was CE-marked under the IVDD by self-declaration or by certification with a Notified Body. The following timelines apply:

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Legacy Products Under IVDR
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Legacy devices under IVDR

IVDR replaces IVDD with phased implementation.

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Quality Management System Requirements under IVDR 2017/746
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IVDR QM System Requirements

Ensure IVDR QMS compliance and audit readiness.

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Technical Documentation
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IVDR Technical Documentation submission requirements.

Learn Technical Documentation submission requirements.

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IVDR Sampling Infosheet
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IVDR Sampling Infosheet

Get an overview of IVDR sampling for Class B and C devices' technical documentation.

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IVDR CDx infosheet
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IVDR Companion Diagnostix CDx Infosheet

Learn about IVDR CDx certification and the consultation process.

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IVDR Class D Devices Infosheet
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IVDR Class D Devices Infosheet

Discover the European Regulation on in vitro diagnostic medical devices (EU) 2017/746 (IVDR) with provisions for special scrutiny of high-risk Class D devices.

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Extended IVDR_transition_timelines
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Extended IVDR Transition Timelines

Learn about extension of the IVDR Transition Period Under Regulation (EU) 2024/1860.

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 EU IVDR
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The European In Vitro Diagnostic Medical Device Regulation IVDR

Learn about the IVDR and its device classification.

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IVDR Classification infosheet
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IVDR Classification Infosheet

Learn IVDR risk-based classification for medical devices.

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