EC Adds Four Devices to Manual on Borderline and Classification

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).

For example, the manual says that products intended to facilitate or enable contraception based on measuring BBT — which predicts ovulation by tracking the patient’s body temperature and menstruation days — should be qualified as a medical device. Similarly, the stand-alone software intended to act as a natural method of birth control should also be qualified as a device.

Trial prosthesis heads and stems are surgically invasive devices but aren’t reusable surgical tools, so they should be considered class IIa devices, according to the manual.

Read the updated manual here: www.fdanews.com/11-08-18-BorderlineManual.pdf. — James Miessler