Our allergy & autoimmune test portfolios are now available in accordance with IVDR
The European regulation on in vitro diagnostic medical devices (IVDR) has created a regulatory framework for the manufacturing of IVD devices placed in the EU market, setting higher standards for quality and safety. The process for CE certification has moved from self-certification to an independent third-party certification, with increased traceability throughout the supply chain.
We have received our EU quality management certificates and signed the relevant Declarations of Conformity (DoCs) from our EU notified body (GMED, identification number CE 0459) and can now offer our full* immunodiagnostics menu — comprised of ImmunoCAP™ allergy and EliA™ autoimmunity portfolios run on Phadia™ Laboratory Systems — in accordance with IVDR.
Ensuring a smooth transition in your laboratory
The transition to IVDR-labelled products will happen sequentially as we deliver the remaining in-stock IVDD-labelled products first. IVDD-labelled and IVDR-labelled products can be used interchangeably during the transition period as set by the EU Commission/Parliament, and there are no requirements in the regulation for laboratories to revalidate tests or change ordering processes. There is no need to communicate changes to patients or clinicians as they will not be impacted by IVDR.
Availability of IVDR-labelled products and Directions for Use (DFUs) |
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| May 2022 |
Phadia instruments, Phadia Prime software, Phadia system reagents, EliA Stool Extraction Kit 2, EliA Stool Extraction Kit plus, EliA diluents |
| June 2022 | IImmunoCAP test portfolio, ImmunoCAP ISAC E112i test Updated ImmunoCAP DFUs published & new labels on products |
| End of 2022 |
ImmunoCAP Rapid Adult test, ImmunoCAP Rapid Wheeze/Rhinitis Child test Updated ImmunoCAP DFUs published & new labels on products |
| End of 2024 | EliA test portfolio* Updated EliA DFUs published & new labels on products |
* EliA™ ssDNA and EliA™ Anti-IgA tests will not be made available under IVDR at this time. These tests will continue to be available in their In-vitro-Diagnostic Device Directive 98/79/EG (IVDD) compliant status during the applicable transition period.
Thermo Fisher Scientific is a global leader in allergy and autoimmune diagnostics.
Support
Along with practice parameters and guidelines for clinicians, Thermo Fisher Scientific provides clinical and laboratory training and support, including enhanced clinical insights beyond results.
50 years
Phadia AB, owned by Thermo Fisher Scientific, has provided continuous diagnostic innovations for more than five decades.
