CE marking and EU Health Technology Assessment serve different purposes: safety and performance versus relative clinical value. Under the EU HTA Regulation, selected high-risk devices will undergo Joint Clinical Assessments, requiring comparative and patient-relevant evidence beyond traditional regulatory expectations.

The 513(g) Request provides a binding FDA determination on device classification and regulatory requirements, but comes with fees, limited interaction, and often slow timelines. It is most valuable when regulatory status is unclear or confirmation is critical (e.g. general wellness…

A 2026-ready testing strategy must be risk-anchored, standards-driven, and PMS-aware. Manufacturers should integrate biocompatibility, sterilisation, packaging, electrical safety, software lifecycle controls, usability validation, and risk management into a coherent evidence plan that satisfies both UK and EU regulators without duplication.

FDA now requires 14 cybersecurity documents for medical device submissions. Understanding these interconnected reports is key to compliance, patient safety, and faster market access.

Integrating regulatory requirements early in the medical device development process helps startups avoid costly delays, redesigns, and recalls. By embedding risk management, usability, and compliance from the start, teams can reduce testing cycles, speed up CE marking or FDA clearance,…

Medical-grade plastics are essential in healthcare for their safety, biocompatibility, and cost-effectiveness, but their single-use nature creates major environmental and health concerns. Biobased alternatives and small behavioural changes, like reducing unnecessary device use, can significantly cut waste and carbon emissions.