medical device regulation

Europe's medical device notified bodies are sounding the alarm: proposed revisions to the MDR and IVDR could quietly strip away the oversight safeguards that keep patients safe. Here's what's changing — and why it matters.

The U.S. Food and Drug Administration has issued updated guidance on cybersecurity requirements for medical device premarket submissions, aligning more closely with current quality management system standards, emphasizing lifecycle risk management, and encouraging manufacturers to adopt secure product development frameworks.

The UK’s MHRA reported a record surge in medical device testing and approvals in 2025, driven by rapid growth in neurotechnology and AI‑powered innovations. With reduced fees for small companies and faster review times, the Agency is accelerating access to emerging health technologies across the UK.

The FDA has updated its lists of medical devices with digital health technologies, including AI-enabled devices, AR/VR medical devices, and sensor-based digital health technology. These FDA-authorized device lists help healthcare providers understand the current digital health landscape and support informed use of advanced medical technologies in patient care.

The Medical Device Coordination Group (MDCG) of the Commission of the European Union (EU)...

The Commission of the European Union (EU) has updated the list of standards that...

Medical device veteran Jon Speer breaks down the latest changes in the medical device regulatory landscape, both in Europe and the U.S.