The new European Union In Vitro Diagnostic Medical Device Regulation (EU IVDR) was published in the Official Journal of the European Union on May 5th 2017 and “entered into force” 20 days later on 26 May 2017. Readers should be aware that “entry into force” isn’t the same as being applicable. The existing In Vitro Diagnostics Directive (IVDD) remains applicable, as there will be a transition from the current IVDD to the new EU IVDR. The end of the transition coming for the final few devices, potentially as late as 27th May 2025.
The details of the repeal of the current IVDD are described in the new Article 112, with the transitional provisions being described in the new Article 110.
The key dates are as follows;
- Entry into force of the EU IVDR – 26th May 2017
- Earliest date Notified Bodies may apply for designation according to the EU IVDR – 26th Nov. 2017
- Earliest date EUDAMED can go live – 26th Mar. 2020
- Date of application of the EU IVDR – 26th May 2022
- Last possible date for placing devices on the market according to the IVDD (i.e. if not already expired IVDD Notified Body certificates are void) – 26th May 2024
- Last possible date for putting devices into service according the IVDD – 26th May 2025
In theory, the new EU IVDR could be adopted by manufacturers of medical devices immediately after its entry into force in May 2017. In practice however, the new infrastructure required by the EU IVDR; the new EUDAMED portal, the new registration and reporting procedures etc., will not be put in place by the European authorities for several years and transitional arrangements will almost certainly have to be put in place. Neither will any of the new Notified Bodies be designated under the new EU IVDR immediately after publication. Initial estimates suggest the first of the newly designated Notified Bodies will only be able to accept applications for product approvals sometime around the middle of 2018. Meaning with the first devices requiring Notified Body approval under the new EU IVDR may not be approved until close to 2019.
This page will be updated as more precise dates are known.