Update about the implementation of the IVDR

  • During the 5 year transition period until May 26th 2022, DiaSys has the choice continue to comply with the In Vitro Diagnostic Medical Devices Directive (IVDD) or to comply with the In Vitro Diagnostic Medical Devices Regulation (IVDR). From May 26th 2022 on, products can only be placed on the market under the IVDR (with certain exceptions given under the transitional provisions).
    The transition periods are essential for ensuring a continued supply of CE-marked IVDs to European and international markets. However most products may not be able to comply with the regulations until late in the transition periods, because:
  • The European Commission needs to publish many implementing acts, which are laws needed to implement both regulations. These laws will be gradually published during the transition periods.
  • Notified bodies may only be in place later during the transition periods. Notified bodies are the auditing bodies which certify products and quality management systems – without them most manufacturers cannot choose compliance to the new regulation.
  • A new electronic platform called ‘Eudamed’ is only expected to be operational just before 2020. Compliance to the regulation depends on Eudamed: ~ 75 articles and/or paragraphs in each regulation are related to this new electronic and integrated platform.
  • Regardless if a product is CE-marked under the directives or the regulations, customers will continue to receive DiaSys products with a high level of quality, safety and performance.
  • You can expect to appear new relevant guidance documents at  DG GROW’s dedicated website during the course of 2018 and beyond.