For the manufacturers trying to figure out ways to place their medical devices in the EU market, classifying their devices based on their intended purpose should always be the first step.
As per the EU regulations, the classification is based on the risks involved in the device. It is very important to classify your device during its developmental phase as the device in each risk class has to take a different path for market authorization and the regulatory requirements differ for each class. Also, the device with higher risks has more stringent regulatory and testing requirements.
Manufacturers need to assure that the intended purpose of the device is well specified to determine the class of the device.
For easy identification of the applied rule, medical devices are categorized into Invasive, Non-Invasive, Active Devices, etc. The detailed rules for classification are specified in Annex VIII of EU MDR 2017/745.
Following are the various classification rules and their applicability:
According to the above rules, the devices are to be classified in one of the following classes. This classification helps identify the conformity assessment procedure needed for the device to obtain CE marking. Also, while classifying, if a device falls under more than one class, the highest risk class has to be considered.
Manufacturers of Medical Devices who are looking to get CE Mark can contact us at email@example.com to obtain assistance in identifying the class of your device and to decode the requirements of EU MDR 2017/745.
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Elexes medical consulting is one of the leading regulatory & compliance consultant for several industries: Medical device, Pharmaceuticals, Cosmetics, Food, and Biologics.