FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

European Commission Adds Four Devices to Manual on Borderline and Classification

Nov. 13, 2018
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The European Commission added four new products it considers devices to its Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices, including several related to contraception.

The manual helps devicemakers understand which products the commission considers to be medical devices, especially products and product categories that have previously been subject to doubt. The recommendations aren’t legally binding.

The latest update — version 1.20 — adds trial hip prosthesis heads and stems, stand-alone software applications for conception and contraception purposes using patient-entered data, and products intended to facilitate contraception and enable contraception based on basal body temperature (BBT).

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