Highest Quality standards

Intensifying our commitment of providing high quality products, Immunostep works in accordance with the standard UNE-EN ISO 13485: 2018 (EN ISO 13485: 2016 & ISO 13485: 2016), which meets international standards for medical device and reagent manufacturing.

 International Norms

    UNE-EN ISO 13485: 2018 (EN ISO 13485:2016 & ISO 13485:2016). Health Products. Quality Management Systems. Requisites for regulation purposes, encompassing good manufacturing practices.

    Legislation:

      European: Directive 98/79/EC, 27 October, concerning health products for “in vitro” diagnosis. Spanish: Royal Decree 1662/2000, 29 September, health products for “in vitro” diagnosis.

      System Quality Management

        UNE-EN ISO 13485: 2018 (EN ISO 13485:2016 & ISO 13485:2016) Health Products. Quality management systems. Requirements for regulatory purposes. Valid from 7 February 2023 until 6 February 2026

        IVDR Regulation

        The new EU In Vitro Diagnostic Medical Device Regulation 2017/746 (IVDR) replaces the current EU In Vitro Diagnostic Medical Device Directive (IVDD) (98/79/EC). The IVDR took effect in May 2017, marking the start of a period of transition from 26 May 2022.

        The IVDR ensures a higher level of health and safety for in vitro diagnostic medical devices, and sets new rules for applying the CE mark.

        The biggest change concerns the risk of in vitro diagnostic devices (IVDs) and the role of Notified Bodies (NBs). The IVDR also clarifies the obligations of the parties involved.

        RELEVANT CHANGES IN IVDR

        • Extended product scope;
        • New IVD classification according to risk;
        • Involvement of notified bodies;
        • New requirements and roles for economic operators;
        • Provide a unique and common nomenclature for IVDs;
        • Close post-market surveillance;
        • New rules on technical documentation and clinical evaluation procedures.

        Following the publication of Regulation (EU) 2022/112 Immunostep IVD-CE devices placed on the EU market, could be placed on the market or put into service during this transition period until the following dates:

        • 26 May 2022, Buffers & Solutions Diagnostic devices;
        • 26 May 2025, for Serological SARS-CoV-2 Diagnostic devices;
        • 26 May 2026, for Cell Analysis devices;
        • 26 May 2027, for Platelet autoantibody detection devices.

        CURRENT STATUS OF IMMUNOSTEP

        We have a wide portfolio of IVDD products in our catalog of our IMMUNOLOGY product line. You are welcome to check all of them by clicking on the link.

        On the other hand, Immunostep will continue offering their IVD-CE products during this transition phase. Additionally, we are working to obtain new conformity assessment according to the Regulation (EU) 2017/746 with the involvement of a notified body, both in the current products, and in the upcoming ones, without interrupting the supply of products to customers.

        For any query or doubt about a determinate product regarding this topic, we are pleased to help. You can contact us via email at tech@immunostep.com

        Contact

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        LOCATION:

        Centro Investigación del Cáncer (C.I.C) Avda. Universidad de Coimbra, s/n Campus Miguel de Unamuno 37007 Salamanca

        +34 923 294 827 

        info@immunostep.com

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