A manufacturer is developing a bioresorbable plug classified under which category if it is "wholly or mainly absorbed"?

The classification of medical devices within the European Union's Medical Device Regulation (MDR) is essential for determining the regulatory pathway for a product. For a bioresorbable plug that is "wholly or mainly absorbed," the appropriate classification is under Rule 8 of Annex IX, which pertains to devices that are intended to introduce substances into the body or that are absorbed by the body.

A Class III device is reserved for products that are either implantable or present a significant risk to the patient, which aligns with the nature of a bioresorbable plug. Since this specific device is designed to be fully absorbed or mainly absorbed by the body, it fits the criteria of Rule 8. This rule applies to implantable devices or those that are intended to have a biological effect and can be classified as high-risk due to their interaction with bodily tissues.

The device's intended use and its absorption characteristics necessitate a thorough evaluation to ensure that it meets safety and efficacy standards, thus warranting its classification as a Class III device. Since it involves significant changes within the body and has the potential for notable effects, it is rightly placed in this higher-risk category, reflecting the regulatory requirements needed to guarantee its safety for patients.