CE Marking for Medical Devices

CE marking demonstrates that your product meets the legislative requirements of your industry, including health and safety, and is fit for purpose.

It’s a legal requirement for many medical device products to have a formally registered CE Mark. This is law in the EU but this registration is also demanded by other countries outside of the EU where they respect what goes into such a registration. We assist in the creation of the registration application, collaborating with the client for the technical file (since the client will know technically more than we do) and ensuring the format of the application is correct before submission thus resulting in saved time and money.

To place a CE mark on your product, you’ll need to:

As a manufacturer, by placing the CE mark you are declaring that your product conforms to the correct legislation whether or not you are selling the product within the EU.

We have Qualitators qualified to guide you through the process of getting a CE mark for your product. They can give you advice on which assessment body to use, write the necessary technical papers and review what you have written.