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Glossary Term
Class IIb Medical Devices (EU)
Definition
Class IIb Medical Devices are moderate-to-high-risk devices that typically have a longer duration of use, more invasive applications, or are used to sustain or monitor critical patient functions. Under the EU Medical Device Regulation (MDR), these devices require a high level of regulatory oversight, including thorough clinical evaluations, conformity assessments by a Notified Body, and post-market surveillance.
Relevance to the MedTech Industry
Class IIb devices address critical or complex healthcare needs, such as life-supporting functions or invasive diagnostic and therapeutic applications. They require robust development, testing, and monitoring to ensure patient safety and compliance with stringent regulatory standards.
Additional Information & Related Terms
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