In the wake of omnomicsNGS gaining the CE-IVD mark under the In-Vitro Diagnostics Directive (IVDD 98/79/EC), Euformatics Quality Engineer Iina Kivimäki breaks down what the mark actually means, why it is important, and why you as a clinician doing variant interpretation of NGS samples should choose IVD certified tools. The world of CE-marking can often be confusing and for many it is unclear exactly what the value of the marking is and why it matters to them. Here, we try to demystify CE-IVD and explain what it means for you.

What does it mean to be IVDD certified and how does it help in moving towards IVDR compliance?

omnomicsNGS has been certified as a CE-IVD device under the In-Vitro Diagnostics Directive (IVDD 98/79/EC), moving from its previous marking as a CE-marked medical device class I.

CE-IVD certification under the IVDD is an important preliminary step in the journey to becoming a CE-marked clinical diagnostics tool under the upcoming and legally binding In-Vitro Diagnostics Regulation (IVDR). IVD devices that are registered under the IVDD can become so-called legacy devices under the IVDR starting from 26th of May 2022, specifically for devices that will require notified body assessment when they previously could self-certify their IVD devices.

This means that existing IVD devices have a longer time to adjust to the requirements of the IVDR. This longer transition period is due to the limited number of notified bodies that are approved to assess devices, a crucial difference between the IVDD and IVDR. It is these notified bodies that externally assess whether a device can be certified as an IVD device under IVDR, but at the end of 2021 there are only 6 such bodies in the whole of Europe.

Iina Euformatics Quality Engineer

What is IVDR?

In Vitro Diagnostic Regulation (IVDR 2017/746) will replace IVDD starting from 26th of May 2022, and will be legally binding. This affects all IVD devices in the EEA but also has a global impact, since CE marking is recognised around the world. The IVDR has been designed to increase the safety and effectiveness of in vitro diagnostic devices. As a result, a greater number of devices will be assessed by notified bodies, making the manufacturing and distributing of devices more regulated and transparent.

These notified bodies are independent conformity assessment bodies within the EU that have been granted the credentials to assess if IVD devices in the EAA comply with the IVDR and decide if companies are allowed to CE-mark their product. This is a big deal, as under IVDD, only around 20% of devices required notified bodies in the CE-marking process while under IVDR this number grows to 80%. 

How are IVD devices classified under IVDR?

IVDR classifies devices based on risk classes marked from A to D. Devices in class A are low risk devices for patients, and will continue to be self-certified by the manufacturer. This means that there are no external bodies assessing these devices and the end-user needs to trust that the manufacturer has designed and manufactured the device to be effective and safe to use.

Class B is the default class of IVDR; these devices have a low public health risk and moderate risk to patients.

Class C devices are moderate risk devices, for example devices that are intended for genetic testing.

Class D devices are high risk, for example devices for detecting transmissible agents in blood.

Quality management system is required

The IVDR requires companies manufacturing devices to implement a quality management system to ensure a high standard of quality throughout the organisation and manufacturing process. At Euformatics we are complying with the standards that are relevant in the medical software manufacturing sector, and as part of our work to become IVDR compliant we plan to be ISO 13485 certified in early 2022, solidifying our quality management system. Complying with the standard is proof that our company and product development function according to a defined quality system, in turn helping us to continue to produce safe IVD software. 

Genetic testing under IVDR

The IVDR also affects laboratories doing genetic testing. Laboratory-developed tests are covered by the regulation if equivalent devices are on the market. In that case, all the requirements of the IVDR need to be met by the laboratory themselves. 

If IVD devices are manufactured and used only within a health institution, these devices need to comply with the General Safety and Performance Requirements set forth in Annex I of the IVDR and comply with ISO 15189 requirements for quality and competence of medical laboratories. 

This means of course that IVDR will affect basically every organisation providing genetic testing services in one way or another, either by requiring additional compliance for laboratory-developed tests, or IVD certified products bought from external suppliers.

The future of omnomicsNGS

As IVDR comes into force in 2022 we will of course be making sure that we follow it. Validation of genomic variant interpretation is a challenge, but as NGS technologies continue to make a positive impact on the way we treat diseases and NGS-based testing gains further traction globally, we want to be at the forefront of providing the software tools needed to get the most out of the data.

Why should you choose an IVD certified variant interpretation and reporting tool?

IVD certification is proof of compliance with current regulations and the standards that go with them. You can trust that the manufacturer of a CE-IVD marked device has validated and continues to validate their device for its intended use and takes actions to improve the product to ensure that they are safe and effective. And remember, if a CE-marked device under the IVDR can be found on the market, it should always be preferred over research use only devices in tendering processes for clinical applications. 

If you are doing NGS tests and want to be compliant with IVDR then please get in touch. We would be glad to work with you to help ensure that you are IVDR compliant.

To find out for yourself how omnomicsNGS can make a difference to the way you work and book your free demo today.


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