EU Council adopts amendments delaying IVDR deadlines

Corrected 30 May 2024*

The European Council has adopted amendments to the In Vitro Diagnostic Medical Device Regulation (IVDR) that delay conformity assessment deadlines to prevent regional test shortages. The measures will also accelerate the adoption of the European database on medical devices (EUDAMED) and require manufacturers to give six-month notifications to their Competent Authorities about potential shortages for certain products.

“In 2017, new rules were introduced to modernize and update the EU framework for IVDs, guaranteeing their safety and effectiveness,” the Council said. “The amendment adopted today extends the deadline for transitioning to the new system under certain conditions, to avoid shortages of critical IVDs without compromising on safety.”
 
While IVDR was adopted in 2017 and has been in effect since May 2022, the test makers and EU authorities have raised concerns that products are not transitioning to IVDR quickly enough, potentially leading to critical shortages if the previous deadlines remained in place.
 
In January, the European Commission proposed updating the IVDR deadlines to give manufacturers more time to recertify their products to avoid such a scenario. Following that, the EU Council endorsed the measure after reaching an agreement with the European Parliament in February. (RELATED: Commission proposes to extend IVDR transition, accelerate EUDAMED adoption, Regulatory Focus 23 January 2024)
 
“It is very likely that many safe and critical in vitro diagnostic medical devices, which are essential for the medical diagnosis and treatment of patients, would not be certified in accordance with [regulation] before the end of the transitional periods,” said the amended regulation states. “This leads to a risk of shortages, especially of highest-risk (class D) devices, by the end of the current transitional period on 26 May 2025. It is therefore necessary to ensure that there is an uninterrupted market supply of in vitro diagnostic medical devices in the Union.”
 
Under the amended regulation class D devices need to come into conformance by 31 December 2027; class C devices have until 31 December 2028, and class B and class A sterile devices have until 31 December 2029.
 
MedTech Europe commented on the timeline extension, stating that while it supports the move, many manufacturers are not transitioning to the IVDR because the conformity assessment process is slow and resource-intensive. It is asking for a "sharp reduction" in administrative requirements, shorter assessment timelines, and more predictability to remedy the situation.
 
The amended regulation also stated that the original plan was for all seven modules of EUDAMED to be adopted once they were all up and running. However, the electronic system for clinical investigations and performance studies has been significantly delayed. With that in mind, the amendment requires stakeholders to use the individual Eudamed modules as they go live.
 
"The use of the electronic systems that are completed or that are about to be completed would largely support the effective and efficient implementation of [regulations], decreasing the administrative burden for economic operators," the regulation states. "A gradual roll-out of the individual electronic systems of Eudamed should therefore be allowed once their functionality has been verified in accordance with the
procedure laid down in [regulation]."
 
MedTech Europe said that it welcomed the gradual Eudamed roll-out said the modules need to be fully developed and tested.
 
“User onboarding and training for accessing the playground and the database must be available,” the group added. “EUDAMED also needs to enable the most efficient use of Notified Body and Manufacturer resources, requiring improvements in usability and functionality. Pragmatic timelines and the elimination of redundancy in national databases are imperative for a seamless transition.”
 
The amended regulation also requires medtech manufacturers to notify their competent authorities, health institutions and healthcare providers of a product shortage six months before they suspect a product interruption or discontinuation that could be a public health concern.
 
“While the industry supports the intention, this requirement needs to be proportionally scoped and executed efficiently and should only apply to situations where the interruption lasts at least 90 days,” said MedTech Europe in response to the notification requirement. “Last but not least, reporting at the EU level should supersede any national reporting requirements that have been or are planned to be implemented.”
 
The amended regulation will take effect once it is published in the Official Journal of the European Union.
 
Statement

*A previous version of this story incorrectly listed class A devices instead of class B and class A sterile devices. Regulatory Focus regrets the error.