NEWS & INSIGHT

The article summarizes the key regulatory domains, highlighting areas of alignment across MDR/IVDR and the AI Act (EU) 2024/1689, while also calling out the additional obligations that AI manufacturers must now implement without delay.

Predetermined Change Control Plan (PCCP) in FDA marketing submissions for AI-enabled medical devices, to avoid additional submissions.

The EU Artificial Intelligence Act approved by the European Commission, is a pioneering regulatory framework aimed at overseeing artificial intelligence technologies within the EU. The Act came into force on 1 August 2024. This landmark legislation categorizes AI systems based on their risk levels - unacceptable, high, limited, and minimal- introducing stringent requirements, particularly for high-risk applications. The AI Act's primary goals are to ensure safety, promote

The FDA’s 510(k) process is a key regulatory pathway for medical devices seeking market clearance in the United States, allowing companies to demonstrate that their device is substantially equivalent (SE) to an existing legally marketed device, known as a predicate. This pathway enables faster market entry when compared to a full premarket approval (PMA) and is particularly beneficial for low- to moderate-risk devices. Here’s a breakdown of the review process, timeline, and t

In today’s highly competitive global marketplace, the ability to bring new products to market swiftly and efficiently is a critical determinant of success. However, navigating the complex medical devices regulatory landscapes of different regions—especially the US and EU —can pose significant challenges for companies looking to expedite their time to market. A well-crafted regulatory strategy that is tailored to the specific requirements of these regions can not only speed up

The FDA's Breakthrough Devices Program has a goal to provide timely access to innovative medical devices by speeding up review process.

Many diagnostic tests are commonly used for the clinical diagnosis of human diseases or conditions and in determining the state of health, such as cholesterol levels, AI-based software as a medical device (SaMD) for providing therapeutic recommendations based on genetic profiling, etc. These products are intended for use in the collection, preparation, and examination of specimens taken from the human body, such as blood, tissue, urine, and saliva. Some test kits available i

The EU Medical Device Regulation (MDR, 2017/745/EU) came into force on May 25th, 2017. Legacy medical devices that comply with the Medical Device Directive (MDD, 93/42/EEC) and are covered by a notified body certificate may benefit from the MDR transition timeline extension published in 2023 by the European Union. The transition deadline for Class III and IIB implantable devices has been extended to December 2027, while the transition for Class IIB non-implantable devices, Cl

Many medical device companies are developing CDS tools to improve clinical practices and health outcomes. In this growing market, there are various types of CDS tools, including those that follow clinician prescriptions and send alerts, as well as AI-based software that analyzes patient data to assist with diagnosis and treatment decisions. Distinguishing between CDS tools that are regulated by the FDA and those that are exempt can be challenging. This article aims to provide

Navigating the regulatory landscape for medical devices and in-vitro diagnostics (IVDs) can be a complex and challenging task. To...

Regulatory labeling requirements for medical devices are constantly changing, presenting a challenge for manufacturers and distributors who must comply with various country-specific registration requirements. US Food & Drug Administration (FDA): High-quality labeling is necessary to ensure device performance as well as patient and user safety. Therefore, the use of FDA-recognized labeling standards is highly recommended and can facilitate your approval/clearance process. FDA