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Sample Prep and Molecular Biology IVD-R Transition Updates
The EU legislation for in vitro diagnostic (IVD) medical devices, In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR), was applied on May 26, 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 regulation.
To this effect, we have been working diligently to ensure that the Applied Biosystems MagMAX Viral/Pathogen II (MVP II) Nucleic Acid Isolation Kit (Cat. No. A48383), and VeritiPro Dx Thermal Cycler will be compliant with the regulations and be labeled with the CE mark. These products in the sample preparation workflow provide sample collection to extraction results, for further downstream analysis.
Find out more about Thermo Scientific KingFisher Apex Dx system, Applied Biosystems MagMAX Viral/Pathogen II (MVP II) Nucleic Acid Isolation Kit, Applied Biosystems VeritiPro Dx Thermal Cycler and related consumables in the question and answer section below.
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Your questions, answered
Q. Will the KingFisher Apex Dx Nucleic Acid Purification System have an official In Vitro Diagnostic (IVD) version available?
A. Yes. Currently the KingFisher Apex Dx is available. Contact a sales representative here
Q. Will the KingFisher Apex Dx 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. Contact a sales representative here
Q. What other countries will the KingFisher Apex Dx 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 Apex Dx. Contact a sales representative here
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. Contact a sales representative here
Q. Will I need IVD KingFisher plastics for the KingFisher Apex Dx?
A. No, you can continue to use KingFisher plastic consumables, currently available as For Laboratory Use (GPLE), on the IVD version of the instruments.
Q. Will the existing MagMAX Viral/Pathogen II Nucleic Acid Isolation Kit (Cat. No. A48383) be approved for use in the European Union (EU) and be IVDR compliant?
A. Yes, the MagMAX Viral/Pathogen II Nucleic Acid Isolation Kit (Cat# A48383) is compliant under IVDR regulation. It is available for purchase in the EU. More information about the product's IVDR status can be found here. Subscribe to receive product updates.
Q. Will the MagMAX Viral/Pathogen II Nucleic Acid Isolation Kit (Cat# A48383) be approved for use in the United Kingdom (UKCA)?
A.Yes, the MagMAX Viral/Pathogen 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 2023. Subscribe to receive product updates.
Q. How does this affect the MagMAX Viral/Pathogen II Nucleic Acid Isolation Kit (Cat# A48383) I purchased in 2021?
A. There is no impact to the MagMAX Viral/Pathogen Nucleic Acid Isolation Kit (Cat# A48383) manufactured in 2021. Customers may continue to use the product post May 26, 2022. The product shelf life has been extended to 24 months in select countries only and availability is subject to term and conditions. Please check with your country specific representative for more information. Subscribe to receive product updates.
Q. Will the VeritiPro Thermal Cycler have an official In Vitro Diagnostic (IVD) version available?
A. Yes. Currently VeritiPro Dx Thermal cycler is available. Learn more
Q. When will the VeritiPro Dx Thermal Cycler be available?
A. VeritiPro Dx thermal cycler was launched in June 2023. Download brochure
Q. Will the VeritiPro Dx Thermal Cycler also be approved for use in the United Kingdom (UKCA)?
A. Yes, VeritiPro Dx Thermal Cycler conforms to UK Medical devices regulations 2002 and is UKCA labeled in UK.
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 VeritiPro Dx. Contact a sales representative
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 be IVDR compliant due to new legislation replacing IVDD in May 2022. To address the need for an IVDR-compliant Thermal cycler, we have launched CE-IVD labeled VeritiPro Dx Thermal cycler. Explore now
Q. Will Veriti Dx be available for sale?
A. No, Veriti Dx will be discontinued in North America and select countries in Europe by June 30, 2024. Learn more
For In-Vitro Diagnostic Use