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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A. Yes. Currently the KingFisher Apex Dx is available. Contact a sales representative here
A. Yes, it is planned to be approved in the UK. Contact a sales representative here
A. We are currently evaluating country-by-country approvals for Apex Dx. Contact a sales representative here
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
A. No, you can continue to use KingFisher plastic consumables, currently available as For Laboratory Use (GPLE), on the IVD version of the instruments.
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.
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.
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.
A. VeritiPro Dx thermal cycler was launched in June 2023. Download brochure
A. Yes, VeritiPro Dx Thermal Cycler conforms to UK Medical devices regulations 2002 and is UKCA labeled in UK.
A. We are currently evaluating country-by-country approvals for VeritiPro Dx. Contact a sales representative
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.
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
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