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Testing and Certification of Medical Technologies

Safe electric medical devices

For example, we perform the following tests:
• Electrical safety (60601 series)
• EMC test (60601-1-2)
• Radio tests, for products supporting wireless communication, such as Bluetooth, Wifi, 4G and RFID
• Cybersecurity Assessment

DEKRA Product Testing and DEKRA Notified Body

You can test the product in risk class 1 by yourself and affix a CE marking on it yourself as well. So, it doesn’t require inspection by a Notified Body but if you don’t have the know-how or capacity in-house to test your product in risk class 1, DEKRA’s Product Testing experts will be only too glad to help. If the test results are positive, we can issue a declaration stating that your product meets the CE guidelines. You will not be issued with a CE certificate, but will nevertheless be allowed to put a CE mark on your product.
If the product are in risk class 2 or higher, the product must be certified by a Notified Body before being put onto the market. A Notified Body will request technical documentation which will show that the product is safe. The technical documentation consists primarily of test reports carried out, for example, by DEKRA or other laboratories. In addition, it also includes certificates for the relevant standards. These are drawn up, for example by DEKRA, or other test centers. A Notified Body will also look at other aspects of the product, such as its function and any clinical studies. After gaining approval, your product will be issued with a CE certificate by the Notified Body. Only then can your product be sold on the market.

Get in touch with an expert of medical devices testing

Would you like to know more about testing and certification of medical technologies? We are happy to help you! Fill in the form below to get in touch with an expert to discuss the process and aks questions about the service.