The countdown has started. On 26th of May the In Vitro Diagnostic Regulation, also known as IVDR, is entering into force. The aim of the regulation is to establish a robust, transparent, predictable, and sustainable regulatory framework for in vitro diagnostic devices (IVDs), which ensures a high level of safety and health whilst supporting innovation.
In addition, the intention from the European Commission with the new legislation is also to achieve a better harmonization within the EU. Several requirements that were earlier only present in guidelines, have now been incorporated within the regulation, which also include requirements of transparency. This is good news!
But there is a need for new guidances. We can all look into the list of expected guidances on the European Commission webpage and face the fact that there are several delays, which can be challenging. And after the finalization of the planned guidelines, there will be a need for further guidances. In the absence of guidances, you really have to dig into the IVDR itself.
However, the main challenge is the limited number of notified bodies. Consequently, the European Commission had to act and decided upon a progressive roll-out of IVDR regarding some aspects. You may find the decision (2022/112) in Eurlex. The progressive roll-out does not change any of the requirements of the IVDR, but extends the time available to complete the conformity assessment with notified bodies.
So, how can we take advantage of the extra time? If you, like the majority of IVD-manufacturer, have limited or no earlier experience of notified body conformity assessment, this extra time is valuable to get to know the regulation and update your documentation.
My advice for you as manufacturer of IVDs is to focus on the main intention of the IVDR -the access of safe and effective devices on the market. Take the opportunity to reassure that you device is safe and effective, and your documentation updated. Start by making Annex I your friend. If you think that this is too challenging – there are always specialists, like us, ready to support you on the way.
When the time comes – you will be more than ready for the assessment of conformity by the notified body.
Senior consultant, expert in IVD/IVDR regulations
Photocred: Julia Koblitz/Unsplash