IVD-R transition updates

The new EU legislation for in vitro diagnostic (IVD) medical devices, In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746, will be applied on May 26, 2022, after the five-year transition period has ended. Thermo Fisher Scientific is committed to supporting clinical laboratories across the EU in preparation for the transition to this new regulation.

To this effect, we have been working diligently to ensure that the Thermo Scientific KingFisher Apex Automated Purification systems, Applied Biosystems MagMAX Viral/Pathogen II Nucleic Acid Isolation Kit (MVP II), and Applied Biosystems VeritiPro Thermal Cycler will be compliant with the regulations and be labeled with the CE mark in 2022. These products in the sample preparation workflow provide sample collection to extraction results, for further downstream analysis for infectious disease testing.

Find out more about Thermo Scientific KingFisher Apex Purification System, Applied Biosystems MagMAX Viral/Pathogen II (MVP II) Nucleic Acid Isolation Kit, Applied Biosystems VeritiPro Thermal Cycler and related consumables in the question and answer section below.

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Your questions, answered

KingFisher Apex for IVDR

Q. Will the KingFisher Apex Nucleic Acid Purification System have an official In Vitro Diagnostic (IVD) version available?

A. Yes. Currently the KingFisher Apex is available only as General Purpose Lab Equipment (GPLE) version.
With the upcoming IVDR regulations going into effect on May 26, 2022, Thermo Fisher is planning to launch an official In Vitro Diagnostic (IVD) version of the KingFisher Apex. Subscribe to receive updates on availability.

Q. When will the KingFisher Apex Nucleic Acid Purification Systems IVD version be available?

A.Subscribe to receive updates on availability of an IVD version of the KingFisher Apex Nucleic Acid Purification System.

Q. Will the KingFisher Apex Nucleic Acid Purification Systems also be approved for use in the United Kingdom (UKCA)?

A. Yes, it is planned to be approved in the UK. Subscribe to receive updates on availability.

Q. What other countries will the KingFisher Apex Nucleic Acid Purification Systems be approved for when using in an In Vitro Diagnostic (IVD) setting/workflow?

A. We are currently evaluating country-by-country approvals for the upcoming In Vitro Diagnostic (IVD) version of KingFisher Apex. Subscribe to receive updates on availability.

Q. How does this affect the KingFisher Apex Nucleic Acid Purification System that I purchased?

A. If your current workflow includes the KingFisher Apex, you may be eligible to trade-in your current instrument for one that is IVD-approved (once available). Please discuss the option of our trade-in/trade-up program with a sales representative. Subscribe to receive updates on availability.

Q. Will I need IVD KingFisher plastics for the KingFisher Apex IVD?

A. No, you can continue to use KingFisher plastic consumables, currently available as For Laboratory Use (GPLE), on the IVD version of the instruments.
MagMAX Viral/Pathogen II (MVP II) Nucleic Acid Isolation Kit for IVDR

Q. Will the existing MagMAX Viral/Pathogen II (MVP II) Nucleic Acid Isolation Kit (Cat# A48383) be approved for use in the European Union (EU) and be IVDR compliant?

A. Yes, the MagMAX Viral/Pathogen II (MVP II) Nucleic Acid Isolation Kit (Cat# A48383) is planned to be approved by and available for purchase in the EU and be IVDR compliant. More information about the product's IVDR status will be announced in early 2022. Subscribe to receive product updates.

Q. Will the MagMAX Viral/Pathogen II (MVP II) Nucleic Acid Isolation Kit (Cat# A48383) be approved for use in the United Kingdom (UKCA)?

A.Yes, the MagMAX Viral/Pathogen II (MVP II) Nucleic Acid Isolation Kit (Cat# A48383) is planned to be approved by and available for purchase in the UK. More information about the product's UKCA status will be announced in early 2022. Subscribe to receive product updates.

Q. How does this affect the MagMAX Viral/Pathogen II (MVP II) Nucleic Acid Isolation Kit (Cat# A48383) I purchased in 2021?

A. There is no impact to the MagMAX Viral/Pathogen (MVP II) Nucleic Acid Isolation Kit (Cat# A48383) manufactured in 2021. Customers may continue to use the product post May 26, 2022. Subscribe to receive product updates.
VeritiPro Dx Thermal Cycler for IVDR

Q. Will the VeritiPro Thermal Cycler have an official In Vitro Diagnostic (IVD) version available?

A. Yes. Currently, the VeritiPro Thermal Cycler is available on the marketplace for both Research Use Only (RUO) and General Purpose Lab Equipment (GPLE) settings and workflows. With the upcoming IVDR regulations going into effect on May 26, 2022, Thermo Fisher is planning to launch an official In Vitro Diagnostic (IVD) version of VeritiPro (VeritiPro Dx) Thermal Cycler. Subscribe to receive updates on availability.

Q. When will the VeritiPro Dx Thermal Cycler be available?

A. The system with CE-IVD marking (IVDR and FDA approved) will be announced in the first half of 2023 and orders will be taken at that time. Subscribe to receive updates on availability.

Q. Will the VeritiPro Dx Thermal Cycler also be approved for use in the United Kingdom (UKCA)?

A. Yes, VeritiPro Dx Thermal Cycler is planned to be approved by and available for purchase in the UK starting in the first half of 2023. Subscribe to receive updates on availability.

Q. What other countries will the VeritiPro Dx Thermal Cycler be approved for when using in an In Vitro Diagnostic (IVD) setting/workflow?

A. We are currently evaluating country-by-country approvals for the upcoming In Vitro Diagnostic (IVD) version VeritiPro Dx Thermal Cycler. Subscribe to receive updates on availability.

Q. How does this affect the Applied Biosystems PCR Plastics I will need to run the VeritiPro Dx Thermal Cycler?

A. All PCR plastics, seals, and tubes are considered general laboratory consumables and are not In Vitro Diagnostic (IVD) devices, which means that PCR plastics will not be regulated under the European IVDR. By the beginning of 2023, the RUO label will be removed from all PCR plastics produced, since PCR plastics are not regulated under IVDR, the RUO label can be misleading. The change in labeling has been assessed in accordance with IVDR (EU) 2017/746 and MDCG 2020-16 Guidance on Classification Rules for In Vitro Diagnostic Medical Device under Regulation (EU) 2017/746.

Q. Will the existing Veriti Dx Thermal Cycler be IVDR compliant?

A. No, Veriti Dx will NOT become IVDR compliant, when the new legislation replaces IVDD in May of 2022. To address the need for an IVDR-compliant thermal cycler, Thermo Fisher Scientific will launch a Dx version of the VeritiPro Thermal Cycler in the first half of 2023. Subscribe to receive updates on availability.
For In-Vitro Diagnostic Use