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  • Scott replied to the topic Classification in FDA Vs EU in the forum EU Regulatory Basics 7 years, 12 months ago

    In the US, nonabsorbable sutures can be classified as Class II with moderate risk of injury. In addition, absorbable sutures can be classified as Class II. In EU it is considered Class IIb medium to high risk if it is nonabsorable. However, if it is absorbable it is considered Class III. Essentially, the sutures classification is based on the structure of the suture. For Class II sutures they are made up of cotton or linen fibers or coated natural or synthetic fibers in which the coating contributes to suture thickness without adding strength. For Class III sutures they are made up of metal wire of monofilament or multifilament construction.