Notified bodies are advising manufacturers to make their applications according to Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) immediately, in particular for class D IVDs or they are in danger of non-compliance when the deadlines arrive. The EU body industry association, TEAM-NB has insisted on action for diagnostics manufacturers who need to comply with the IVDR to keep their products on the market. Notified bodies have the capacity to take on applications under the IVDR and accomplish the conformity assessment process early enough if the applications are put forward at once.
On the other hand, if they are not submitted in time, a notified body cannot ensure that the conformity assessments and certifications will be processed before the transition timelines come to an end. This could lead to problems in the supply chain and access to IVDs in the EU.
The European Commission printed the results of a survey showing that the initial conformity assessment process can take 6-12 months for low to medium risk devices (covered by quality annex certificates) and 13-18 months for high-risk devices (covered by a product annex certificate). With this in mind, as well as the fact that the deadline for class D devices is 26 May 2025 and the current timelines for conformity assessment, it is vital for manufacturers to contact a notified body at once and submit their applications right away. It is strongly advised to submit the applications for class D devices before the end of this year, so that technical documentation assessments can start early enough.
Source: Medtech Insight (an Informa product)
Accompanying this subject we recommend the following content on our website
- Team-NB position papers on MDR and IVDR technical documentation
- MDR extended transition timelines and removal of MDR and IVDR sell-off period adopted
- MDCG publishes guidance on significant changes for legacy products under the IVDR
- IVD medical devices after the IVDR date of application