In the European Union, CE mark medical device is a legal necessity for placing a device on the market. CE mark medical device indicates that a specific maker has verified that the product meets all critical standards or has been evaluated by a certified conformance body based on the device class.
You must categorize the device and determine the suitable compliance analysis model for your product to know which standards you must fulfill. This establishes the activities that must be completed to assert conformance.
The main idea behind CE marking was to create standardized product regulations across all European states, enabling cross-border trade easier and more efficient for businesses.
Waiting duration in obtaining a CE mark medical device certification
Because there are still so few notified bodies, the compliance evaluation process may take a lengthy period. A Notified Body audit might take anywhere from six months to 12 months to commence.
In contrast, it was usually a quarter under the MDD. Between an audit and approval, it might take anywhere from two to seven months. It took so long because more regulations were added due to the EU MDR, particularly for the QMS. As a result, the entire procedure becomes more complicated and time-consuming.
Procedures for obtaining a CE Mark medical device approval
Medical equipment can be classified into four risk groups for compliance evaluation processes. The categorization guidelines are rooted in the human body’s susceptibility and the possible risks linked with the equipment’s technical design and manufacturing.
Only medical devices in the lowest risk category are exempt from the necessity for a notified entity to be involved in the conformity assessment process. The conformity assessment is carried out on behalf of the medical device manufacturers by the notified bodies, which are governmentally third-party entities that are impartial.
Provided the notified body is certified by the proper government in the corresponding EEA state and encompasses the appropriate device category, the manufacturer has complete freedom in selecting it.