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Glossary Term
Class IIa Medical Devices (EU)
Definition
Class IIa Medical Devices are devices with a lower-to-moderate risk profile that are intended for short-term use or have a less invasive interaction with the human body compared to Class IIb devices. Under the EU Medical Device Regulation (MDR), these devices require more stringent regulatory controls than Class I devices, including technical documentation, conformity assessments, and post-market surveillance.
Relevance to the MedTech Industry
Class IIa devices provide vital medical functionalities while maintaining a lower risk of harm due to their intended purpose and usage. They fill the space between low-risk Class I devices and the higher-risk Class IIb devices, ensuring safety and performance through moderate regulatory oversight.
Additional Information & Related Terms
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