A manufacturer is developing bioresorbable devices sold as a kit. What is the classification of the bioresorbable plug?

The classification of the bioresorbable plug as a Class III device per Annex IX, Rule 8 is correct because this rule specifically addresses devices that are "wholly or mainly absorbed." Class III devices typically present a higher risk and are subject to the most stringent regulatory controls since they can sustain prolonged contact with the body or are intended for long-term use.

In the context of bioresorbable devices, the fact that they are designed to be absorbed by the body after fulfilling their purpose indicates that they have significant implications for patient safety and effectiveness. These devices require thorough evaluation and clinical evidence to demonstrate their safety and performance over the duration of their intended use.

The reference to Annex IX, Rule 8 directly pertains to devices with such absorption characteristics, reinforcing the designation of Class III. This classification also aligns with the regulatory perspective that materials intended for prolonged interaction and eventual degradation within the body require rigorous oversight to mitigate risks associated with their breakdown and interaction with biological systems.