Commission proposes to extend IVDR transition, accelerate EUDAMED adoption

Concerned that in vitro diagnostic manufacturers don’t have enough time to comply with the In Vitro Diagnostic Medical Devices Regulation (IVDR), the European Commission (EC) has again proposed extending the regulation’s transition period. At the same time, the Commission has proposed to accelerate the timeline for complying with EUDAMED requirements, by making the use of finalized modules mandatory on a gradual basis.

While IVDR entered into force in May 2022, the transition periods for diagnostics to comply with the regulation were extended in late 2021 amid pressure from industry and fears of a market collapse for diagnostics. At the time, the EU extended the transition periods to 26 May 2025 for high-risk IVDs, 26 May 2026 for moderate-risk IVDs, and 26 May 2027 for lower-risk IVDs. The Commission now said it wants to give manufacturers more time, as a significant number of IVDs on the market have not yet taken the necessary steps to come into compliance.

“The situation is especially critical for high-risk IVDs, which are devices used, for example, to test for infections in blood and organ donations,” the Commission said. “To improve the availability of such essential devices, today's proposal gives more time for manufacturers to apply the new rules, under certain conditions, without compromising safety requirements.”

“This is very important, also taking into account the fact that many manufacturers producing IVDs are small and medium size enterprises [SME],” the Commission added.

Under the new proposal, high-risk class D diagnostics would get until December 2027 to undergo a conformity assessment under IVDR; class C, or high individual and/or moderate public health risk tests, will have until December 2028, and low risk class A sterile and class B tests would have the deadline extended to December 2029.

The proposal requires companies to warn the authorities if they anticipate an interruption to the supply of IVDs or medical devices at least six months prior, so that member states can respond faster to potential product shortages.

Sabina Hoekstra-van den Bosch, global director of regulatory strategy of NBCG-Med/TÜV SÜD, told Focus that, in principle, EC’s proposed timeline should give manufacturers enough time to make the transition and for notified bodies to certify them, but much of it depends on the manufacturers taking advantage of the extended timeframe.

Gert Bos, executive director at Qserve, agreed with the assessment and added that manufacturers need to step up.

“The new timelines with the current notified body capacity would be enough,” Bos told Focus. “With ways to continue without reference labs, it could all work, but only if the IVD industry changes from the ‘don’t get your foot off the gas’ to ‘push that gas pedal down and then accelerate!’”

EUDAMED rollout

The European Commission is also proposing to make some EUDAMED modules mandatory by late 2025. Under the current regulations, EUDAMED will not become mandatory until all 6 of its modules are in place; however, under its proposed revisions, EUDAMED compliance would be rolled out gradually, “as soon as [the modules] have been audited and declared functional.”

Three EUDAMED modules have been available to manufacturers for voluntary use since December 2020 and October 2021, but the other modules are not expected to be available until the second quarter of 2024 and the third quarter of 2026.

The Commission notes that EUDAMED is critical to the implementation of MDR and IVDR because it and the competent authorities need the data EUDAMED will gather to monitor potential product shortages in the EU market. Furthermore, it can prevent companies from registering their product multiple times and streamline product information reporting on the national level.

With that in mind, EC is proposing to require mandatory adherence to several modules in EUDAMED right after they’ve been audited and found to be functional starting in the fourth quarter of 2025.

“The use of EUDAMED – and especially its systems for the registration of economic operators, devices and certificates – will improve transparency and provide information on devices on the EU market, helping to monitor the availability of devices,” said the Commission.

Bos said that while EC has some estimates based on input from industry and notified bodies, its data is far from accurate, which is likely why the commission wants to make EUDAMED use mandatory sooner.

“One of the reasons for the EUDAMED database actually is that in the future we would have such key data available,” he added. “In the text there is significant emphasis on the importance of EUDAMED, as it will help authorities and others make better informed decisions.”

Bos noted that a major criticism from manufacturers and notified bodies is that they have had to jump through hoops to get their information into EUDAMED, and the Commission has had issues getting their software to work. He said manufacturers and notified bodies should not have to wait for all the modules to go live before entering their data.

“The sooner data in some modules is entered, the more information there will be on the availability, quality, and safety of devices and IVDs,” he added.

Hoekstra-van den Bosch agreed with the assessment that EC needs EUDAMED data to understand potential product shortages.

“On EU Commission’s request, notified bodies have supported them by providing their most recent data for Class D IVDs, but this is limited to information on what notified bodies have received, not on what is still out there,” she said. “So, one of the proposal’s provisions aims at getting prospective information on which devices and IVDs with important consequences for public health will disappear from the market.”

Hoekstra-van den Bosch noted that this isn’t the first time the EUDAMED deadlines have had to be moved, and initially, there was expectation that the last modules would be operational by 2022.

“The main issues are in the module for clinical investigations,” she noted. “So once this proposal is accepted, it is expected that the modules on economic operators, devices and certificates are ready to go fairly soon. This will bring important benefits to the entire sector.”

Bos said that ultimately, all the stakeholders involved need to believe in the new regulations and work toward coming into compliance.

“If we get this right, the implementation will be finished 12.5 years after publication, and 22 years after the start of the revision process,” he said.

“We’re all in this because we care: We care about patients, about smooth healthcare processes, and IVD is critical in that, as without many test, we jump back in healthcare status, easily back to the seventies,” he added. “Having said that, hospitals likely will pick up much in-house production of tests, as they will be allowed under the IVDR and maybe that is not the intent, but it is good to have that ultimate safety net.”

Next, the Commission will ask the European Parliament and Council to adopt its proposed IVDR revisions. The Commission also noted that it will start working on preparatory work for the targeted evaluation of the medical devices legislation this year.

“The evaluation should assess how the legislation is affecting the availability of devices, in particular for devices with specific characteristics (e.g., pediatrics, orphan, innovative devices),” the Commission said. “In the assessment, special attention may also be given to costs and administrative burdens stemming from the implementation of legislation, especially for SMEs.”

Gert Bos is the chair of RAPS and Sabina Hoekstra-van den Bosch is a director of RAPS, a nonpartisan, nonprofit professional society. Their comments represent their views only.

Press release, proposal

Commission proposes to extend IVDR transition, accelerate EUDAMED adoption

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