As Prescribed

There have been a number of recent regulatory developments affecting medical devices and in vitro diagnostic devices in the EU, building on the European Commission’s proposal to simplify the medical devices regime published at the end of 2025, and in the UK. These developments include procedural requirements for notified bodies’ conformity assessment activities under the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR), political agreement on amendments to the EU Artificial Intelligence Act, and significant reforms to the UK medical devices regime.

A recently issued Food and Drug Administration (FDA) Warning Letter citing a drug manufacturer for improper use of artificial intelligence (AI) suggests FDA’s scrutiny of AI is expanding. Although not the first FDA Warning Letter related to AI, prior Warning Letters focused on issues surrounding the regulatory status of the AI systems themselves, namely whether a given AI system was a medical device subject to FDA oversight.

The FDA released updates to two guidance documents on January 6: General Wellness: Policy for Low Risk Devices (General Wellness) and Clinical Decision Support Software (CDS). FDA did not issue a traditional press release; instead, FDA Commissioner Makary took to social media to announce the updates in a video, in which he touted them as “promot[ing] more innovation with AI and medical devices” and that FDA has “a clear lane for medical grade products,” but needs “to adapt with the times and be proactive with guidance.” Consistent with the Commissioner’s messaging, the updates to the General Wellness guidance expand the types of products that qualify for enforcement discretion (i.e., do not need to comply with FDA’s device requirements). The updates to the CDS guidance, however, do not appear to significantly modify FDA’s interpretation of the CDS exemption. Nonetheless, these updated guidance documents signal FDA leadership’s willingness to ease regulatory burdens for digital health and wearables.

On December 15, 2025, the US Food and Drug Administration (FDA) issued a press release announcing that FDA eliminated a major barrier to the use of real-world evidence (RWE) in medical device regulatory submissions. Namely, for certain types of medical device submissions, sponsors may not need to provide individually identifiable source data when using RWE. FDA also indicated that it intends to consider making a similar change for drugs and biologics signaling that there could be a broader shift in FDA policy coming, meaning that medical product developers of all types should be paying attention to FDA developments in this area.

The US Food and Drug Administration’s (FDA’s) Breakthrough Devices Program was established to facilitate earlier patient access to novel medical devices addressing serious health conditions, by offering prioritized review and enhanced communication with regulators. Despite its promise, only a small percentage of devices granted Breakthrough designation have achieved marketing authorization, reflecting persistent regulatory and evidentiary hurdles.

In a pre-Christmas gift, the European Commission has adopted a proposal to simplify Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR): Proposal for a regulation to simplify rules on medical and in vitro diagnostic devices. The key elements of the revisions are summarized in a factsheet and in a questions and answers document.

On December 8, 2025, FDA announced a pilot for certain digital health devices in connection with the Center for Medicare and Medical Innovation’s (CMMI’s) Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) payment model.

The European Commission, by its decision dated 26 November 2025, confirmed the functionality of four modules within the European database on medical devices (EUDAMED).

In June 2025, the US Food and Drug Administration (FDA) issued a final guidance titled Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions (2025 Cybersecurity Guidance). This guidance updates the 2023 guidance of the same title with the agency’s interpretation of and compliance recommendations for new requirements for “cyber devices” under Section 524B of the Federal Food, Drug, and Cosmetic Act (FFDCA). These new statutory cybersecurity requirements, enacted in December 2022 as part of the Food and Drug Omnibus Reform Act (FDORA), are starting to take centerstage as the medical device sector begins to address new enforcement risks for cybersecurity deficiencies under more traditional fraud and abuse laws, such as the False Claims Act (FCA).

With the US Food and Drug Administration’s (FDA) September 9, 2025 announcement that it will increase its enforcement of the Federal Food, Drug, and Cosmetics Act (FFDCA), its rules governing direct-to-consumer (DTC) prescription drug advertising, and the subsequent issuance of more than 100 “cease and desist” letters, the agency has demonstrated it believes that DTC marketing of prescription drugs may have gone too far and that it is committed to bringing the industry back into regulatory compliance.