A CE mark medical device is a medical product that meets the general safety and performance requirements, generally referred to as the GSPR of all regulations relevant to the European Medical device. In other words, for your products to be allowed into the European market, they must pass the requirements of all the relevant directives given for that product. It is legally required for you to sell your devices on the European Union market and is claimed by the manufacturer. You must get or have a CE Marking for all your products to sell medical devices and a CE mark medical device is the right tool for the job.
In the European Union, there are four classes of CE mark medical device: I, IIa, IIb, and III. There are requirements that a manufacturer should complete before the CE Mark is added to a medical device and allowed to sell in the European market.
Requirements for Having a CE Mark Medical Device
• The manufacturer must have technical documents that show that the product complies with the relevant requirements and all the procedures directed for the medical device.
• The correct authorities must register the devices.
• The manufacturer must receive a device-specific CE Certificate from a recognized body in the European Union.
Steps to Be Taken by The Manufacturer for The Process to Be Complete
• They should classify their product according to the classification rules present.
• They should determine the certification process according to their device class.
• Should fulfill the necessary requirements.
• As a manufacturer, you should set up a way to monitor your products when they enter the market.
• The manufacturer should find a way to report to the relevant authorities or deal with any accident that can occur and affect their products in the market.
• They should issue a declaration of acting per the set specifications or regulations.
• They should be in a position to save the documentation for five years because a new version is revised after this time.
• The manufacturer should register everything with the relevant authorities.