EC to address the risk of device shortages by amending the MDR/IVDR

Attaining a balance between the ultimate level of safety and feasibility

On 23 January 2024, a proposal for new regulation amending the MDR (Regulation (EU) 2017/745) and the IVDR (Regulation (EU) 2017/746) has been published in the Official Journal of the European Union. With the proposed revision, the Commission mainly aims to safeguard patient care by ensuring the continued availability of certain essential healthcare products, in particular of certain in vitro diagnostic medical devices (IVDs) that play a pivotal role in healthcare. The proposed amendments are of course also intended to have an effect on the medical devices sector as a whole (since they target both the MDR and the IVDR), including by enhancing the transparency in sector through a sped-up launch of some elements of EUDAMED.

Most IVDs are tests done on samples from the human body, such as blood or tissue, that are used to determine the status of the person's health.¹ Popular examples of IVDs are pregnancy tests and COVID-19 tests, but IVDs are used for a wide array of purposes within healthcare, such as HIV testing for blood donation screening or cancer tests, etc..

It goes without saying that ensuring a high level of safety of IVDs is crucial. Therefore, the IVDR has introduced an upgraded conformity assessment system that is much more robust than the one foreseen under the previous regulatory framework. However, the increased safety of IVDs will of course be pointless if such those increased requirements result in IVDs becoming scarce or even unavailable.

The proposed regulation puts forward three measures to achieve the aforementioned objectives of continued availability and increased transparency:

1. A further extension of the transition period for in vitro diagnostic medical devices (IVDs)
2. An expedited and gradual roll-out of EUDAMED
3. An obligation for manufacturers to notify supply disruptions of medical devices and IVDs

In this article, we provide an outline of the context and rationale for the proposed amendments.

Extension of the IVDR transition period

As mentioned above, the most significant change introduced by the IVDR is the upgraded system of conformity assessment, in which the role of the notified has taken on importance.

Under the previous regulatory framework (Directive 98/79/EC), only a relatively small number of high-risk devices was subject to assessment by a notified body (about 8% of the IVDs on the market). Under the IVDR, the percentage of IVDs that will be subject to the scrutiny by notified bodies has increased to 80%.

This change has given rise to availability and capacity issues for notified bodies. Moreover, both manufacturers and notified bodies are challenged by the - sometimes complex - new requirements for new types of devices that are introduced under the IVDR. As a result, the certification of IVDs under the IVDR is proceeding at an agonisingly slow pace, which results in a high risk of shortages of many of those devices.

In summary, manufacturers and notified bodies are in need of more time to complete the mandatory conformity assessment procedures.

The current version of the IVDR already provides for a transition mechanism, as the new requirements will only fully apply as from May 2025 for higher-risk IVDs (such as HIV or hepatitis tests (class D)) and as from May 2027 for lower-risk IVDs.

Under the proposed amendment, a further extension of these transitional periods is foreseen: until December 2027 for high-risk devices, until December 2028 for moderate risk devices (such as cancer tests (class C)) and until December 2029 for lower risk devices (class B, such as pregnancy tests and class A sterile devices, such as blood collection tubes).

The extension is made subject to conditions similar to those adopted in Regulation (EU) 2023/607, which extended the MDR transition period. Imposing such conditions is deemed necessary to support the transition to the IVDR as they ensure that only manufacturers that actively undertake steps to transition to the new requirements are rewarded with additional time.

Expedited and gradual roll-out of EUDAMED

EUDAMED is the new European database on medical devices, which was also introduced by the MDR and the IVDR as one of the key instruments for transparency on medical devices. It aims to provide a real-time overview of medical devices that are made available in the EU and to provide substantial information on such medical devices to the public and healthcare professionals.

EUDAMED is composed of six modules related to: actor registration, unique device identification (UDI) and device registration, notified bodies and certificates, clinical investigations and performance studies, vigilance and market surveillance.

Pursuant to the current rules, the use of EUDAMED is only mandatory once the Commission has confirmed that all six modules are up and running. It should be noted that currently only three of the six EUDAMED modules are functional and available for voluntary use (Actors, UDI/Devices and Notified Bodies/Certificates). Two modules (Market Surveillance and Post-Market Surveillance and Vigilance) are expected to be finalised by Q2 of 2024. The one remaining module (Clinical Investigations/Performance Studies) is not expected to be completed before Q3 of 2026.

However, EUDAMED - and especially the modules for the registration of economic operators and devices - is a valuable tool for monitoring the market and potential shortages of devices. The proposed regulation therefore suggests to gradually make the use of the EUDAMED modules mandatory once they have been declared functional, instead of waiting for the entire system to be complete. The mandatory use of several modules would then start as of Q4 of 2025.

Obligation to notify supply disruptions

Finally, the proposal obliges manufacturers to notify any anticipated disruption in the supply of IVDs or medical devices, allowing Member States to take necessary measures to maintain patient care.

Next Steps

The proposal will now be presented to the European Parliament and Council for approval.

In 2024, the Commission plans to begin preliminary work for a focused evaluation of the medical devices legislation. This evaluation will determine the impact of the legislation on device availability, with particular attention to devices with unique features (e.g., for paediatric use, orphan, or innovative devices). The evaluation will also consider the costs and administrative burdens the legislation imposes, especially on SMEs.

¹ IVDs are not always necessarily tests. For instance, also specimen receptacles are deemed to be IVDs. The full definition of an IVD under the IVDR is “any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information on one or more of the following:
(a) concerning a physiological or pathological process or state;
(b) concerning congenital physical or mental impairments;
(c) concerning the predisposition to a medical condition or a disease;
(d) to determine the safety and compatibility with potential recipients;
(e) to predict treatment response or reactions;
(f) to define or monitoring therapeutic measures.
Specimen receptacles shall also be deemed to be in vitro diagnostic medical devices.”