Is your company as far along as it needs to be?
The In Vitro Diagnostics Regulation, or the IVDR, was created to ensure a greater level of patient protection and regulation around the creation of in vitro diagnostic devices (or IVDs). The IVDR will replace the legacy In Vitro Diagnostic Directive (IVDD) and should ensure a greater level of patient protection and provide rules and regulations that are more effectively implemented.
The manufacturers of these devices are well aware of the IVDR that will soon take effect. Most of these manufacturers are already taking the necessary steps to prepare to comply with this new regulation, but are they as far along in their preparations as they should be?
When comparing the In Vitro Diagnostics Directive (IVDD) and the new In Vitro Diagnostics Regulation (IVDR), the IVDR aims to improve the quality and safety of IVD devices and strengthens the transparency of information and traceability of devices.
The IVDR goes one step further and provides much more guidance on how to comply with these requirements. The IVDR’s additional definitions make regulatory requirements less open to interpretation and help provide a transparent and sustainable regulatory framework.
The certification is expected to be very challenging. Under the In Vitro Diagnostic Directive (IVDD), approximately 80% of IVDs currently on the EU market had been manufacturer self-certified for conformity without the involvement of a notified body. As of May 26, 2022, a new classification system will be in place for IVDs, and a greater number of IVDs will require a Notified Body (NB) for review and certification.
There are no grandfathering provisions for moderate and high-risk devices, meaning companies will have to have their devices certified by May 27, 2022, to be able to distribute the products in the EU.
If IVD companies intend to manufacture and distribute products that are considered moderate or high-risk (Class B, C, D per Annex VIII) under the IVDR, they should have already taken numerous steps toward compliance, as we are already over 60% of the way into the deadline.
Seeing that there is much work to be done and numerous obstacles in the way of achieving Notified Body certification for the IVDR, it is important to accelerate the efforts towards certification.
Regardless of where manufacturers are in their IVDR compliance efforts, there is a good chance that there are several challenges still ahead that could potentially jeopardize their ability to meet the certification deadline of May 27, 2022.
Here are some of the challenges to be aware of to ensure that there are appropriate resources for the certification plan:
That’s where EG Life Sciences can help. We’re well-equipped to support you and your company as you prepare to comply with the IVDR.