To facilitate the interpretation of the Directive on Medical Devices 93/42/EEC with regard to classification and borderline medical devices, a Medical Devices Expert Group chaired by the European Commission was established in order to prepare a guidance manual on this matter. The development of this manual has also been triggered by the need for a common approach within the EU and amongst stakeholders.
So as to keep pace with technological changes, this manual shall be regularly updated. The latest version of the Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices was released on 1st September 2014.
This version provides new guidance on classification of five new devices:
2.Riboflavin solution for treatment of keratoconus;
3.Dentistry products with aluminum chloride used in haemostasia;
5.Software and mobile applications:
•Mobile application for processing ECGs
•Mobile application for the communication between patient and caregivers while giving birth
•Mobile medical application for viewing the anatomy of the human body
This manual may be used as a tool by medical manufacturing companies and European Authorized Representatives to proceed with classification of borderline products. Ascertaining the applicable legislation is the first milestone in order to determine the conformity assessment route for CE marking.
A classification of a medical device can be a very complicated process. 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.