Regulatory Affairs Professionals Society (RAPS)’s Post

EU publishes regulation governing use of AI in medical devices and IVDs Regulatory News | 15 July 2024 | Joanne S. Eglovitch The European Commission has published the finalized text of the Artificial Intelligence Act (AIA) which establishes a legal framework to promote the uptake of “human centric and trustworthy” AI for medical devices, in vitro diagnostic devices (IVDs) and other products. The Act also sets harmonized rules for placing products on the market, and is the world’s first comprehensive AI law, according to the European Parliament.

The European Commission has published the finalized text of the Artificial Intelligence Act (AIA) which establishes a legal framework to promote the uptake of “human centric and trustworthy” AI for medical devices, in vitro diagnostic devices (IVDs) and other products. The text is unchanged from the AI Act adopted by the European Parliament on 13 March. The Act creates the framework for the risk stratification on the AI tech, and for many analysts a large portion of AI’s use in healthcare would be classified under "high-risk". The requirements for high-risk devices will go into effect on 2 August 2026, while the AIA was published in the Official Journal on 12 July and will go into effect on 2 August this year. #artificialintelligence #regulation #AIA #medicaldevices https://lnkd.in/e94YdjWY

This is the third in the series of Emergo by UL’s Regulatory Updates on the European Artificial Intelligence (AI) Act (AIA).   In this Regulatory Update we focus specifically on the AIA and penalties and timelines. We also include definitions which are salient to this and a Table (really more a visual representation) which outlines all the upcoming deadlines. Read the article (with our SME Sade Sobande, RAC) here: https://lnkd.in/gNGbzK9G. Article four is next. Stay tuned for a discussion on high risk medical device systems and the relationship of the European device regulations (Medical Devices Regulations/In Vitro Diagnostic Devices Regulations) and the AIA, as well as the opening of the EU AI office. Series on AIA:  *Regulatory Update 1: history, scope, classification, conformity assessment and operator’s obligations of AIA: https://lnkd.in/gKmePHMe . *Regulatory Update 2: AIA best practices, enforcement and oversight, and AI regulatory sandboxes and real-world testing: https://lnkd.in/g9r6q3_e . #medicaldevice #regulatory #regulatoryaffairs #regulatorycompliance #AIA #nlf #EmergobyUL #weareULSolutions #welovewhatwedo #weloveglobalregulatory

https://buff.ly/4ayoqrE The UK has outlined its stance on regulating AI as a medical device, with the MHRA stating that AI designed for medical purposes is highly likely to fit the criteria of a medical device. Currently, many AI products are categorized as low-risk, allowing them to enter the market without undergoing assessment by a notified body. However, the MHRA anticipates that numerous AI products will be reclassified to higher-risk categories under the new post-Brexit medical device regulatory framework. #MedicalDevices #AIRegulation

While the FDA never approved a Medical Device powered by LLM, this is an active field of interest and development by the US Agency, with the goal of providing clarity on the path and expectations for manufacturers based on their own regulatory science work. Naturally, radiology, as a field where most AI solutions have been reaching the market, is the first focus of the FDA. If anyone says that they know how to approve a Medical Device using an LLM, they don't. Not even the Regulators know, but at Complear, we have been working on the best strategies and working with the ecosystem to overcome current technical limitations. https://lnkd.in/dRgnXKc2

For those wondering where the FDA's Center for Devices & Radiological Health (CDRH) is focusing their efforts in regulating AI/ML-enabled medical devices, this short article released yesterday will give you a glimpse.

Collaborating across FDA centers on responsible and ethical AI innovation🤝 In March, CDRH jointly published a groundbreaking paper titled "Artificial Intelligence & Medical Products: How CBER, CDER, CDRH, and OCP are Working Together." The purpose of this paper was to provide greater transparency regarding how they collaborate to safeguard public health while fostering responsible and ethical innovation. Download the paper here: https://lnkd.in/gPi8CcuX #AIInnovation #HealthcareEthics #FDA #MedicalInnovation #PublicHealth #EthicalAI

"Beware of results if black". How should medical AI be regulated? Lots of software in daily use in hospitals and clinics has never been nor will ever be considered for regulation by the U.S. Food and Drug Administration (FDA). For example, there’s no reason for the FDA to regulate which email clients, spreadsheet programs, or internet browsers should be used in the hospital (though their use still falls under other regulations like privacy laws). On the other end of the spectrum is software used for running X-ray scanners, MRI machines, or other medical algorithms. These are regulated with oversight from the FDA. But what about everything in between? A good read by Simon Spichak for proto.life here: https://lnkd.in/dReMJ4dm #aiinhealthcare #digitalhealth #regulation #healthtech

"Beware of results if black". How should medical AI be regulated? Lots of software in daily use in hospitals and clinics has never been nor will ever be considered for regulation by the U.S. Food and Drug Administration (FDA). For example, there’s no reason for the FDA to regulate which email clients, spreadsheet programs, or internet browsers should be used in the hospital (though their use still falls under other regulations like privacy laws). On the other end of the spectrum is software used for running X-ray scanners, MRI machines, or other medical algorithms. These are regulated with oversight from the FDA. But what about everything in between? A good read by Simon Spichak for proto.life here: https://lnkd.in/dReMJ4dm #aiinhealthcare #digitalhealth #regulation #healthtech

Many have seen the growth in artificial intelligence and machine learning-based medical devices cleared by the FDA. But how can clinical trial data guide our future outlook? Attorney Bradley Merrill Thompson, RAC, explores the information on clinicaltrials.gov, highlighting AI/ML products under investigation for future clinical use. #ArtificialIntelligence #MachineLearning #MedicalDevices