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.
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.
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
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
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:
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 email@example.com
For any information required, please use the form below and we will contact you shortly.