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

        Information on IVDR and the Transition Process

        TRANSITION FROM DIRECTIVE  98/79/EC TO REGULATION (EU) 2017/746 (IVDR)

        On 26 May 2022, Regulation (EU) 2017/746 (IVDR) entered into force, replaces the previous Directive 98/79/EC on the regulation of in vitro diagnostic medical devices (IVD) in vitro diagnostic (IVD) medical devices in the European Union. The IVDR introduces stricter requirements for requirements in terms of conformity assessment, post-market surveillance, risk management and traceability to ensure greater safety and quality of products.

        However, in order to ease the transition and avoid shortages of essential products, the European Commission has established a transition period, allowing products CE marked under Directive 98/79/EC to remain on the market for a limited time.

        LEGACY PERIOD AND TRANSITION PERIODS

        Thanks to the amendments introduced by Regulation (EU) 2022/112 and the more recent Regulation (EU) 2023/607, the deadlines for transition to the IVDR have been extended. In vitro diagnostic devices that were already certified under Directive 98/79/EC can continue to be placed on the market until the following dates, depending on their classification:

        PRODUCT CLASS

        DEADLINE FOR PLACING ON THE MARKET

        Class D (high risk, e.g. testing for communicable diseases). communicable diseases)

        31 December 2027

        Class C (medium-high risk, e.g. blood compatibility testing). blood compatibility tests)

        31 December 2028

        Class B and Class A sterile (low-moderate risk)

        31 December 2029

        To benefit from this extension, products must meet specific requirements, such as not having undergone substantial modifications in their design or intended use and maintaining an adequate post-market surveillance system. In addition, the ‘sell-off period’ has been eliminated, which means that products already placed on the market before the end-of-life dates can continue to be sold until the end of their useful life.

        COMMITMENT TO TRANSITION TO IVDR

        At Immunostep, we are committed to IVDR compliance and are actively working on the certification of our products according to Regulation (EU) 2017/746. Our team has initiated the certification process with the designated Notified Bodies and we ensure that our products will comply with the new regulatory standards within the set deadlines.If you have any questions about the certification status of a specific product or how the IVDR affects our products, please do not hesitate to contact us.

        Contact: [info@immunostep.com]

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