Euro Convergence: Regulators discuss device availability, AI Act, lessons from pharma

Berlin – Representatives of European regulators and health authorities offered assurances that the recent Artificial Intelligence Act (AI Act) is compatible with the Medical Device Regulation (MDR), that they are working to ensure product availability in the region, and other pressing topics during a panel discussion and Q&A at the 2024 RAPS Euro Convergence conference.
 
Leo Hovestadt, director of EU governmental affairs at Elekta, questioned whether European health authorities are prioritizing the availability of medical devices. He said he’s seen more and more manufacturers pulling their products out of Europe, leaving patients with reduced access to treatments.
 
Olga Tkachenko, a policy officer at the European Commission, responded that accessibility is a priority for the Commission and other health authorities.
 
“Of course, it's good to talk about medical devices and their safety and performance, but when there is no device, there's nothing to give to the patients,” she said. “It's absolutely clear for us at the Commission and for everybody else on this panel that that's the case.”
 
Tkachenko said the European Commission is monitoring the market and paying close attention to certain factors, such as product applications and certificates given to medical products. She also noted that they have delayed implementing the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) to ensure patients continue to have access to products.
 
Tkachenko noted that some products may be leaving the market because they don’t meet the evidentiary requirements to continue marketing in the EU, and others may be leaving because newer and better products are coming to market to replace them. She added that a better notification system has been proposed that would allow health authorities and hospitals to track what products may face a shortage on the national level, so they can take actions to ensure patients continue to get treatment.
 
Erica Conway, vice president for European IVD regulatory affairs at MCRA asked the panelists what lessons the medtech sector can learn from the pharmaceutical sector in terms of using orphan drug designation to get products on the market for unmet needs.
 
Alberto Ganan, head of committees and quality assurance at the European Medicines Agency (EMA), said the agency's orphan drug designation has been successful and that certain incentives have led to at least three new orphan drugs coming to market annually. He said that using that experience and incentive system could be useful in getting orphan devices to market.
 
Constantinos Ziogas, head of EMA's small and medium-sized enterprises (SME) office, highlighted the role orphan drug designation and the incentives associated with it have played in helping SMEs get orphan drugs to market. He said the incentives have really helped smaller companies come to the agency to discuss their drug development programs.
 
"If we had to look at tools or mechanisms to support developers in medtech, for example, we could look at the achievements that have been delivered with the orphan regulations," he said.
 
Suzanne Halliday, regulatory vice president at BSI, noted that a task force of notified bodies has defined orphan devices for the first time, and representatives from notified bodies are now working on defining conformity assessment for such products.
 
"We understand that to provide some of the predictability that the manufacturers are asking for, that notified bodies are going to be included in the beginning," she added. "The people that have to make the decisions at the end are included right from the beginning and it is a good example of collaboration."
 
Raquel da Cruz Barros, regulatory affairs manager at Regenity Biosciences, stated there are discrepancies between MDR and the newly passed AI Act, especially regarding software as a medical device (SaMD). She asked how MDR and IVDR experts view the AI Act, and how notified bodies are incorporating it in their work.
 
Tkachenko said that companies seeking marketing authorization for their AI products don’t need to fear that they will face two separate assessments of the same product and argued that MDR is sufficiently flexible on the matter. She also noted that the New Technologies Working Group has been discussing how the AI Act can fit into the current regulatory system, such as whether notified bodies can use designation codes, and whether certain existing codes are sufficient for such devices.
 
"It's all about: Does the device perform as intended,” said Tkachenko. “There's nothing specific that I see blocking devices using artificial intelligence coming on the market."
 
Halliday agreed with Tkachenko and stated that notified bodies are ready to receive AI product applications. She added that there already are MDR and IVDR certificates that can be applied to AI products, and the AI Act is just catching up with the most innovative manufacturers. She added that notified bodies have been gearing up for AI products by hiring people with expertise in areas such as fuzzy logic and natural language programming.
 
“We also are starting to purchase software that does conformity assessment of software,” said Halliday. “People don't read 80,000 lines of computer code; they get tested by software.”
 
“So yes, we're ready to do it. Yes, we're already doing it,” she added. “Go ahead, bring the innovation.”
 
Ziogas added that the Big Data Steering Group is leading several AI initiatives at EMA. One such initiative is a detailed AI Workplan that includes developing a reflection paper on using AI to develop medicines, which is expected to be finalized this year.
 
"There's a lot of things ongoing and I think you need to watch the space and look on the EMA website in terms of different activities and documents that will be finalized in the next couple of years," he added.
 
Elizabeth Gfoeller, corporate director for regulatory affairs at MED-EL, said that her company was an early adopter of MDR, having received certification for their hearing implants in March 2020. While she appreciates all the initiatives to help transition companies to MDR, she said it's too late for companies such as hers, who had to endure many growing pains.
 
Gfoeller asked the panel where stakeholders should go to understand how to navigate the current market, considering the complexities of the law, the slew of guidances that are coming out, and all the regulatory uncertainties.
 
Tkachenko said the first step is for stakeholders to read the legislation to try to understand it and pointed to documents on the European Commission website that can help them quickly grasp the regulations. For manufacturers who want specific help understanding the current landscape, she said they should first reach out to the competent authorities to get more targeted advice based on their particular issue.
 
An audience member pointed out that they feel bombarded with regulations, and that it is sometimes difficult to navigate to the right documents. They asked if the health authorities would consider setting up a centralized portal and potentially using AI to help stakeholders navigate the regulations.
 
Tkachenko noted that reducing bureaucratic burdens was a priority for the Commission, and they have been talking about setting up an IT system for that purpose, but there needs to be buy-in from other stakeholders.
 
The panelists were also asked whether EMA's Clinical Trials Information System (CTIS) and the European database on medical devices (EUDAMED) will get an interface and when stakeholders can expect that to become functional. They were also asked if the device information section of CTIS would get an update.
 
Halliday noted that the European Parliament has voted to allow each module of EUDAMED to become functional as they are completed rather than for them all to go into effect simultaneously. The proposal is currently with the European Council for their input.
 
Halliday said the first three modules to go into effect are for the registration of manufacturers, devices, and notified body certificates that stakeholders can voluntarily adopt. She also noted that the clinical trial module is not ready yet, though completion dates have been proposed.
 
Tkachenko said that the available modules will undergo nine months of auditing starting this summer, ultimately leading to a public notice. She said they will be mandatory several months after the notice is put out, which means they'll likely come into effect in January 2026. She also implored manufacturers and other stakeholders to use the modules now while they're voluntary to avoid facing problems in the future.
 
"It's best to get your data into EUDAMED now as soon as possible because if you wait until the last minute when the module becomes available, we will run into a lot of problems," said Tkachenko.
 
Tkachenko added that the clinical investigations and performance studies (CIPS) module is planned to be completed by the third quarter of 2026, and the EUDAMED development team is also working on a "minimum viable" simple interface for CTIS.

Editor's note: This article was updated on 10 May 2024 to add the name of an attendee who asked a question during the panel discussion.