Fearing some crucial hospital products could become unavailable with mandatory implementation of the In Vitro Diagnostic Regulation (IVDR), the European Commission has proposed extending deadlines under certain conditionsi.
While the extension affects all IVDs that apply and meet the extension requirements, the proposal is particularly important for high-risk Class D products, which had been expected to transition by May 2025ii. These are products considered high-risk, for example, to detect “the presence of, or exposure to, a transmissible agent in blood, blood components, cells, tissues or organs, or in any of their derivatives, in order to assess their suitability for transfusion, transplantation or cell administration”iii.
Given the nature of Class D products, the time to get through all processes needed to transition would exceed the time left to transition. Under certain circumstances, some elements of the product may need to reviewed by an expert panel and/or tested by an EU reference laboratory (EURL)3. However, reference labs were only designated in December 2023 and it’s possible manufacturers may have waited to get greater certainty about the requirements.
A number of other issues have likely held manufacturers back from already transitioning to the IVDR. These include:
- A shortage of notified bodies.
- Delays in completing all EUDAMED modules. Currently three of the six are available and two more are expected to become available in 2024iv.
- Insufficient guidance documents from the European Commission
While there are now a greater number of notified bodies, not all are equipped to review Class D productsv. This is a challenge, given that, under the IVDR, 80% of IVDs require notified body involvement, compared with just 20% under the In Vitro Diagnostic Directivevi.
With so many manufacturers now requiring this relationship, delays were inevitable. Aside from finding a notified body to support them, manufacturers needed time to establish these new business relationships and create new agreements. For many small manufacturers, even knowing how to speak to a notified body is potentially challenging: what are their expectations, and how should they prepare their technical documentation? As our experience has shown, in many cases manufacturers’ technical documentation is often not up to requirements because it has not been subject to strict conformity assessments before.
Some IVD manufacturers might have hundreds of products in their portfolio, but if those haven’t been through a notified body before, it’s very likely information will be missing. Collecting required design history data for a legacy device may be challenging and time consuming.
Conditions for extension
To be considered for the extension, manufacturers are expected to meet certain conditions.
For those devices that require an assessment by a notified body, manufacturers must apply to a notified body to transfer to the IVDR by 26 May 2025 for a Class D device and by 26 May 2026 for a Class C device. For Class A and B devices, that requirement is May 20272. They must also have a IVDR compliant QMS in place no later than 26 May 2025.
Other important conditions include:
- That there are no significant changes in the design or intended purpose of the devices
- That the device doesn’t present an unacceptable risk to the health or safety of patients, other persons, or to other aspects of the protection of public health
Manufacturers are also expected to give advanced notice if they expect a supply interruption. This will give Member States more time to take steps to safeguard patients1. This is an important new step since there isn’t much transparency into which devices are available on the EU market and which won’t continue to be available under the new legislation. While this information could be registered in EUDAMED, it isn’t mandatory in all EU/EEA member states as EUDAMED is not yet fully functional. There are some exceptions, for example, Finland requires certain operators to notify EUDAMED when they registervii..
As part of its proposal to extend deadlines, the commission is also proposing a gradual roll-out of EUDAMED. In so doing, rather than waiting for all modules to be available before making use of the database mandatory, the commission is recommending gradual implementation of EUDAMED modules once they have been audited and declared functional2.
If a class D IVD manufacturer isn’t willing to transform under the new Regulations, it’s likely those products will no longer be available after May 2025. And, if a majority of manufacturers of a certain product class make that same decision, it could lead to a situation where all such products – many of which are widely used in hospitals — are no longer available on the market. There will be a need for new technologies and new ways of working, but until that happens hospitals might lack supply for some products they use in procedures. Products intended for small patient groups, such as rare diseases, could be impacted by the cost of meeting stringent requirements for regulatory compliance.
However, the commission is providing financial support to ensure the availability of medical devices and IVDs and is working with various stakeholders to support industry with complying with the rules. Additionally, the commission plans to evaluate the legislation with regards to product availability and to support the development of innovative devices2.
Given the potential issues to meeting these strict requirements, urgent action is needed to safeguard the availability of diagnostics on European markets.
What steps are you taking with regards to your IVDs? What challenges are you facing? We would like to hear your concerns.
About the author:
Tiina Riihimaki is Director | International Service Lead (ISL) MDS Europe, Cencora PharmaLex.
