Navigating The Process of CE Marking For Medical Devices With Ascent EMIRATES
The European Union has always been a leader in medical device regulation. In 2017, the European Union introduced a new set of regulations to ensure the safety and efficacy of medical devices. These regulations are called Medical Device Regulation (MDR) 2017/745.
European Medical Device Regulation 2017/745 is the latest version of the regulation and applies to all medical devices entering the European market. The MDD was the first EU regulatory framework for medical devices and was in place from 1993 to 2017.
The CE Marking For Medical Devices is a requirement that all medical devices sold in the European Union (EU) meet the essential requirements of the Medical Device Directive and other applicable EU legislation. The CE marking is a declaration by the manufacturer that the medical device meets all the essential requirements of the MDD and other applicable EU legislation.
The CE marking must be affixed to the product, or its packaging or documentation, together with the identification number of the notified body that issued the CE certificate. The CE Mark Medical Device Requirements will be a useful tool for communicating the safety of your device and for increasing your brand awareness.