In Europe, before a medical device is launched into the EEA (European Economic Area), it must first bear the CE mark to officially make it a CE mark medical device. When a medical device bears this mark, it means that it meets certain vital requirements that are set by the European General Medical Devices Directive. This means that the device is both safe and fit to perform the function that it was built for. Additionally, it also means that the CE mark medical device can be marketed and sold freely within the EEA without any restrictions.
However, it is important to note that it is mandatory for a medical device to bear the CE marking even if it was made outside the EEA region and is going to be sold within it. It is the responsibility of the manufacture to follow the due process of obtaining the CE mark and placing it on the medical product if it was manufactured within the EEA region. If by any chance, the product was imported from outside the region, it is the responsibility of the importer to make sure the devices bear this mark.
Assessment routes for conformity of a CE mark medical device
Before a medical device obtains a CE mark, the manufacture must first choose one conformity assessment procedure from the four that are available. The procedure that is chosen shall depend on how the medical device is classified. Medical devices are classified as either Class 1, Class 2a, Class 2b, or class 3.
Generally, these devices are graded according to the associated risk that arises from using them. Some of the factors that are considered when grading a CE mark medical device include whether the device is invasive or not, how long the device is going to be in continuous use, and whether it does contain medicinal products or not. Here the rule of thumb dictates the higher the associated risk that comes from using the product, the tougher the conformity rules.
If you have any idea on a medical device that needs a CE Mark, feel free to contact BAAT medical as they shall get you sorted in no time.