Availability of medical devices

In addition, the IGJ monitors the availability of medical devices. One of our roles is to alert the Ministry of Health, Welfare and Sport and the European Union (EU) to potential shortages of medical devices. We do this, for example, when care providers inform us that some medical devices are or may become unavailable. We also play a role in addressing this problem. We contribute to solutions that prioritise the safety of medical devices and the quality of care.

Causes of shortages

When medical devices are unavailable or are inadequately available in the health care system, we refer to it as a shortage. A shortage may develop gradually and persist over an extended period. However, a shortage may also arise unexpectedly and be of short duration. When there is no suitable alternative for essential medical devices, a shortage can become a critical issue for care providers. This situation can lead to an inability to offer a patient a diagnosis or suitable treatment, or to the diagnosis or treatment being postponed.

Various factors affect the availability of medical devices. For instance, in some cases raw material scarcity or their high prices play a role. Sometimes, issues in the supply chain may arise because of armed conflicts or geopolitical tensions. Shortages could also be a result of the aftermath of the COVID-19 pandemic. At the same time, the demand for medical devices is increasing worldwide.

MDR and IVDR also affect the availability of medical devices

Since 2021 and 2022, new rules are applicable governing compliance for medical devices (the MDR and IVDR). These new rules aim to enhance patient safety by imposing more rigorous safety standards on medical device manufacturers. Requirements for notified bodies have also been tightened. Notified bodies verify whether medical device manufacturers meet legal requirements and issue a CE certificate as proof.

In some cases, manufacturers will choose to withdraw their products entirely from the EU market. In other cases, it remains uncertain whether manufacturers will continue to offer their medical devices on the market under the MDR and IVDR. There are also cases in which manufacturers will fail to secure certification for their medical devices during the transition periods for the MDR and IVDR. These manufacturers will no longer be able to offer their relevant products on the EU market.

Extension of the transition periods: 26 May 2024 is a critical day

Due to the high demand for medical devices, the transition periods for the IVDR were extended in January 2022. On 20 March 2023, the transition periods for the MDR were also extended . This gives market stakeholders more time to comply with the new requirements and obtain CE certificates. CE certificates issued on the basis of directives 90/385/EEC (AIMDD) or 93/42/EEC (MDD) will remain valid beyond 26 May 2024.

At the same time, notified bodies now have sufficient capacity to certify medical devices for compliance with the new rules. The lengthy certification process made it necessary to extend the transition periods.

The possibility of extension only applies to certain medical devices and under the conditions as stated in the Amending Regulation(EU) 2023/607. One of the conditions specifies that any request for the assessment of a medical device by a notified body or for replacing a legacy device must be submitted by 26 May 2024. Only medical devices that are fully compliant with the MDR or that satisfy all of these conditions on 26 May 2024 may be offered on the EU market from that date.

The number of medical devices that will comply with the conditions laid down for the extended transition periods remains uncertain. It is also uncertain which medical devices might disappear from the EU market after 26 May 2024.

The IGJ stresses that medical device manufacturers and distributors, as well as care providers, should be aware that the security of supply of medical devices will be under increased pressure from 26 May 2024. It calls upon all parties to limit the potential consequences for the health care system as much as possible.

Reporting centre for (potential) shortages and other measures to limit shortages

On 20 July 2022, the manufacturer trade organisations Nefemed, Diagned, FHI and FME signed a declaration of intent (in Dutch) at the Ministry of Health, Welfare and Sport on the timely reporting of supply issues by medical device manufacturers.

In addition, Zorginkoop Netwerk Nederland (ZINN) was established. ZINN promotes the accessibility of care that depends on medical devices, among other things by supporting the procurement departments of care providers. ZINN has set up a reporting centre where (potential) medical device shortages can be reported. ZINN will then assist in seeking alternative products.

The IGJ urges manufacturers and distributors to act in line with their declaration of intent. It asks manufacturers and distributors to help identify (potential) shortages and seek alternatives by contacting this reporting centre (in Dutch).

In addition, an extensive European survey has been conducted to obtain more insight into medical device availability. This survey has now resulted in a dashboard with up-to-date figures on the CE certification of medical devices.

What this means for care providers

After 26 May 2024, all medical devices must satisfy the transition provisions. Medical devices that satisfy the AIMDD, MDD or Directive 98/79/EEC (IVDD) and that the manufacturer has supplied to a distributor or care provider before 26 May may still be used. Medical devices that have been procured with a valid CE certificate and that are kept in stock in care institutions may be used up to their expiry date, even if the CE certificate has expired after the transition periods.

Care providers are responsible for safeguarding the quality of the care they provide. Care providers that use medical devices must always verify whether they comply with European product legislation, regardless of the transition periods. See our correspondence (in Dutch) on this.

Notification obligation for manufacturers

A situation in which important or even essential medical devices are no longer available on the European market would be undesirable. Such a situation could in some cases be prevented if manufacturers were to inform healthcare providers that they will no longer be able to supply these devices, giving involved parties time to look for a solution.

As of 10 January 2025, new European legislation will impose a notification obligation on manufacturers that will require them to inform involved authorities, healthcare institutions, healthcare providers and economic operators of any supply interruptions. The Inspectorate believes this notification obligation is an important step in ensuring quality of care. It is important to us that medical devices are not only safe and effective, but also available on time for patients who need them.

For more information on the notification obligation, go to the page on the new European Regulation (EU) 2024/1860, which also includes the notification obligation.