Clinical research is entering a new era. By 2026, the way clinical trials are designed, conducted, and approved in both the European Union and the United States will look very different from the past decade. These changes are driven by two major trends: the full implementation of the EU Clinical Trials Regulation (CTR) and the rise of decentralized and hybrid clinical trial models. The EU Clinical Trials Regulation is now fully in force, requiring all new clinical trials to b

Cell and gene therapies continue to transform the treatment landscape, and by 2026, both the FDA and the European Union will have updated frameworks that reshape how these advanced therapies are developed, approved, and monitored. Companies working in this space must prepare for evolving expectations around safety, manufacturing, and long term follow up. In Europe, the upcoming pharmaceutical legislation reform includes several updates to the Advanced Therapy Medicinal Produc

The FDA’s approach to drug approvals is evolving, and by 2026, pharmaceutical and biotech companies will need to adapt to new expectations for confirmatory trials and the use of real world evidence. These changes are part of the agency’s effort to make the approval process faster while maintaining scientific rigor and public trust. One of the most significant shifts involves the Accelerated Approval pathway. Under new reforms introduced through the Food and Drug Omnibus Refor

The European Union is moving forward with the largest reform of its pharmaceutical legislation in more than two decades.

In vitro diagnostic manufacturers are approaching an important milestone under the European Union’s In Vitro Diagnostic Regulation (IVDR).

Cybersecurity has become a top regulatory priority as medical devices become more connected and software driven.

Artificial intelligence is transforming medical devices and digital health technology, and regulators in both the United States and Europe are preparing new oversight frameworks that will take effect by 2026.

After years of development, the EU’s comprehensive medical device database (EUDAMED) becomes mandatory in phases starting in early 2026.

Medical devices are only as safe and effective as their users’ ability to operate them correctly. Even the most advanced technology can fail if patients or healthcare professionals misunderstand instructions, misuse the device, or encounter confusing interfaces. Regulators now recognize usability and human factors as central to patient safety. In 2025, both FDA and EU regulators are emphasizing patient-centric design, usability validation, and clear labeling. These expectatio

European medical device makers face a key May 26, 2026 deadline under the extended MDR transition timelines.

Medical device companies are no longer judged solely on product safety and regulatory compliance.

On February 2, 2026, the FDA’s Quality Management System Regulation (QMSR) will officially replace the long-standing Quality System Regulation (QSR).

Digital health is no longer a niche within the medical device sector.

In vitro diagnostics (IVDs) form the backbone of modern healthcare, guiding everything from infectious disease management to cancer treatment decisions.

For years, emerging markets were seen as relatively accessible expansion opportunities for medical device manufacturers.

Sterilization is a critical step in the medical device lifecycle. Without it, millions of life-saving devices such as catheters, surgical kits, implants, and diagnostic tools would never reach patients safely.

For decades, Laboratory Developed Tests (LDTs) operated under an unusual carve-out in U.S. regulation.

Medical device regulation has long been criticized as fragmented and duplicative. A manufacturer seeking approval in multiple countries...

Data integrity has always been fundamental to regulatory compliance, but in 2025 it is squarely in the spotlight.

Regulatory enforcement is often the best barometer of what agencies truly care about. While guidance documents and speeches provide...