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.


      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.

      IVDR Regulation

      For in vitro diagnostic medical devices for which manufacturers issued the declaration of conformity themselves without the involvement of a notified body before May 26, 2022 and which, under the IVDR, must undergo a conformity assessment procedure with the involvement of a notified body according to the IVDR classification rules, Regulation (EU) 2022/112 defines differentiated transition periods for in vitro diagnostic devices (IVDs), depending on the respective risk class of the device and the date of placing on the market.

      These are as follows:

      • Class D (i.e Sars- CoV-2 kits) products must be adapted by 2025 May 26;
      • Class C (i.e immunology antibodies and HeMoStep Kit) have a transit period until 2026 May 26;
      • Class B products, as well as Class A products distributed sterile (i.e Platelet autoantibody detection and apoptosis kits), must be brought into compliance by 2027 May 26;
      • Class A products non-sterile (i.e diagnostic buffers and solutions), must be according IVDR since 2022 May 26.

      Since 2023 march 20,  Regulation (EU) 2023/607 has been in force and the sell-off period for in vitro diagnostic medical devices, has been abolished. It allows companies to make their products available on the market or put them into service without time restrictions if they were lawfully placed on the market before May 26, 2022, under the previous EU Directive on IVDs.


      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


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