NEW VERSION OF THE BORDERLINE AND CLASSIFICATION MANUAL FOR THE MEDICAL DEVICES AND IVDs.
On October 30th, the European Commission published a new version (Version 1.20) of the Borderline and Classification Manual for Medical Devices and In-vitro Medical Devices for the second time in 2018. The manual aims to facilitate the interpretation of the Medical Devices Directive (MDD) with regard to classification and borderline medical devices.
The new version provides new guidance on six different items: 2 regarding borderline products, 1 regarding classification and 3 regarding Software and mobile applications.’
Borderline: Medical Intended Purpose
· Mattress covers against mites.
· Lubricants intended for body massages and/or sexual intercourse.
· Trial hip prothesis heads or stems.
Software and Mobile Applications
· Product intended to facilitate conception based on basal body temperature.
· Product intended to facilitate conception and enable contraception based on basal body temperature.
· Stand-alone software application for conception and contraception purposes using data entered by the patient.
Borderline products and classification of a medical device can be a complex process, and even confusing once the new Medical Devices Regulation (MDR) is fully applied. Obelis offers Device Classification Confirmation Services so as to help medical equipment manufacturers confirm the classification of their devices.
To know more about the new version of the Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices, please contact us.