In Vitro Diagnostic Regulation (IVDR) Certification Services

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The EU In Vitro Diagnostic Medical Device Regulation (IVDR) 2017/746 went into force on May 26, 2017, replacing the EU In Vitro Diagnostic Medical Devices Directive (IVDD). This certification is essential for manufacturers looking to market their devices within the EU.

Place your in vitro diagnostic medical devices on the EU market

This white paper provides a detailed roadmap for manufacturers looking to transition their legacy IVDs from IVDD to IVDR. Understand transitional provisions, risk classification chances, technical documentation updates, quality management system compliance, how to engage with Notified Bodies and more.
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Learn the technical documentation requirements of In Vitro Medical Device Regulation (IVDR) EU 2017/746, understand what notified bodies are looking for and why technical documentation needs to be ‘live’ documents covering the full product life cycle.
USA / Canada

TRAINING: In-Vitro Diagnostic Regulation (IVDR) Technical Documentation Training

IVDR Resources

The IVDR regulates in vitro diagnostic medical devices placed on the EU market. It aims to enhance the safety and efficacy of IVDs, safeguard patient health and establish a clear and reliable framework for both manufacturers and healthcare providers.

Key changes from the IVDD include:

Expanded scope of products to be considered IVDs
Changes in device classification (from Class A devices with the lowest risk to Class D devices with the highest risk)
Stricter oversight of manufacturers by NBs
Enhanced requirements for post-market surveillance
Increased transparent through the Unique Device
Identification (UDI) system and the European Database on Medical Devices (EUDAMED)

What is the IVDR?

Why SGS?

A Recognized Auditing Organization (AO) for the Medical Device Single Audit Program (MDSAP)

An Approved Body (0120) for the UKCA mark

A Notified Body in Finland (0598) for Software as a Medical Device (SaMD) certification

A Notified Body in Belgium (1639) for the IVDR and Medical Device Regulation (MDR)

WHITE PAPER: How to Get Legacy Devices to IVDR Compliance

WHITE PAPER: Understanding the EU In Vitro Diagnostic Regulation (IVDR) and its impact

Gain insights into key changes in classification and clinical evidence requirements, the role of the Notified Body, strategies for successful compliance with IVDR requirements, the impact on manufacturers and turning challenges into opportunities.
Download

If your in vitro diagnostic medical devices are already certified under the IVDD, you must lodge a formal application for conformity assessment with a Notified Body by one of the following deadlines, depending on the risk class of your device:

May 26, 2025: devices covered by an IVDD certificate and Class D devices that were self-declared under the IVDD
May 26, 2026: Class C devices that were self-declared under the IVDD
May 26, 2027: Class B devices and Class A sterile devices that were self-declared under the IVDD

You must also sign a written agreement with a Notified Body up to four months after the relevant deadline and have an IVDR-compliant QMS in place.

Transitioning from IVDD to IVDR

As a designated IVDR notified body, SGS can perform conformity assessment for a wide range of your IVD devices, including:

Immunogenetics, genetics of cancer and inherited conditions
Cancer markers
Infectious disease markers
Clinical biochemistry and other general analytes
Sterile IVDs
In vitro diagnostic medical device software (IVD MDSW)
Self-tests and near-patient tests

We will issue you a certificate for your in vitro medical device following a successful conformity assessment. This enables you to affix the CE mark to your device and legally place it on the EU market. Your certificate then must be renewed every five years and is subject to annual surveillance, post-market follow-up, sampling and/or testing.

Getting your CE mark from SGS

We are the world's leading testing, inspection and certification company, with decades of experience and expertise in medical devices regulatory compliance. We are: