The new European Union (EU) legislation for in vitro diagnostic (IVD) medical devices, In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746, was applied on 26 May 2022 after the five-year transition period ended. Thermo Fisher Scientific is committed to supporting clinical laboratories across the EU in preparation for the transition to this new regulation.
We are also fully committed to developing and marketing CE-marked IVD devices for molecular diagnostics. In response to the IVDR, we have implemented a transition programme with the objective of ensuring future IVD devices are CE-marked according to IVD-R.
New IVD-R compliant qPCR solutions are in development and will cover focused respiratory viruses, sexual health, and enteric panels.
To stay up to date on clinical testing solutions for infectious diseases and receive updates on IVDR information from Thermo Fisher Scientific, please contact our team.
Yes, the current TaqPath COVID-19 CE-IVD assays will be manufactured and stocked by Thermo Fisher Scientific until May 2025. They can be sold until May 2026 and used by the customer until end of shelf life.
Yes, there is no need for customers with (today’s) IVDD compliant COVID-19 workflow to ‘upgrade’ to IVD-R. By 26 May 2022, all TaqPath COVID-19 CE-IVD declarations of conformity issued under IVDD before this date may remain valid until May 2026.
Yes, new Thermo Fisher Scientific IVD-R compliant solutions are in development, covering focused respiratory, sexual health, and enteric panels.
The new IVD regulations applied from 26 May 2022.
On 7 June 2022, the Applied Biosystems QuantStudio 5 Dx Real-Time PCR System launched and complies with IVDR regulations.
On 12 September 2022, the Applied Biosystems QuantStudio 7 Pro Dx Real-Time PCR System launched and complies with IVDR regulations.
Instruments placed on the EU market prior to 26 May 2022 may still be used after this date, as long as they are supported by Thermo Fisher Scientific Service & Support. CE-IVD labelled products don't lose their CE-IVD label even if the new regulation is fully applicable.
New IVD-R compliant instruments are under development, anticipated in 2022, including new Applied Biosystems QuantStudio 5 Dx and Applied Biosystems QuantStudio 7 Pro Dx instruments.
Yes, the current KingFisher instruments placed in the market prior to May 2022 as part of our CE-IVD TaqPath COVID-19 workflow will remain in compliance until end of service and support.
Yes, the current MagMAX Viral Pathogen II extraction kit will be manufactured and stocked by Thermo Fisher Scientific until May 2022, sold until May 2023, and used by customers until end of shelf life.
As of August 2022, the new lot of the MagMAX Viral Pathogen II extraction kit, IVDR (Cat. No A48383), has the following change: IVDR compliance—upgraded from CE-In Vitro Diagnostic Medical Devices Direction (IVDD) to CE-In Vitro Diagnostic Regulation (IVDR).
Yes, Thermo Fisher Scientific is fully committed to developing and marketing CE-marked IVD devices for molecular diagnostics. To this end, Thermo Fisher Scientific has run a transition programme with the objective to ensure future IVD devices are CE-marked according to IVD-R.
The IVDR deadline: How will it impact the diagnostics industry?
This article was written by Manoj S. Gandhi in conjunction with our team at Finn Partners. It was published in Clinical Lab Manager and gives an overview on the transition to the new regulations, and what the guidelines are for Class A-D.
As IVDR date of application arrives in Europe, challenges to implementation remain
This article in 360Dx quotes both Manoj S. Gandhi and Darleen Welford, our UK-based regulatory affairs director. They discuss how IVDR has prompted companies throughout the industry to make significant changes in how they operate, as well as how relationships with notified bodies and trade associations have helped the transition.
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Analytical validation and performance verification—key components for IVDR compliance
IVDR transition—impact and opportunities for a molecular pathology laboratory
Overcome the complexities of your In Vitro Diagnostic Regulation (IVDR) transition. We’re with you through this rough terrain.
The IVDR transition will bring positive changes to EU regulation of medical devices and lab-developed tests. It also presents potential obstacles, which we can help you overcome quickly. With our ability to help ensure your compliance, supply consistency, validation, and scalability, we offer clarity and confidence for your IVDR transition.
According to the European Commission (EC), the In Vitro Medical Devices Regulation (EU) 2017/746 (IVDR) is a new regulation which will create a robust, transparent, and sustainable regulatory framework that improves clinical safety and creates fair market access for manufacturers and healthcare professionals. The EC states that the IVDR brings EU legislation into line with technical advances, changes in medical science and progress in law-making. IVDR has binding legal enforcement throughout all EU member states and it sets higher standards for quality and safety of IVD devices. For further information on the IVDR, please visit the European Commission website.
In 2022 the EU will begin to enforce the transition from the current In Vitro Diagnostic Medical Devices Directive 98/79/EC (IVDD) to the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) for clinical diagnostic applications.
On 26 May 2022 the IVDR becomes effective, meaning after that date any new IVD devices placed on the market must be CE-marked according to IVDR.
A recent amendment by the commission to the implementation of the IVDR allows some existing products (excluding class A non-sterile devices) to continue to be placed on the market in compliance with the IVDD. The length of the extension is dependent on risk class.
All IVDs manufactured with a CE mark will be affected by the IVDR.
As the world leader in serving science, we are fully committed to developing and marketing IVD devices for molecular diagnostics. To this end, we are running a cross-functional, global programme with the objective of ensuring future IVD devices are CE-marked according to IVDR.
