Safety is a key requirement for any product. Our experts will test your product against the applicable standards. This way we can determine whether your electrical medical device is safe. 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
The risk class of the device determines whether a test needs to be performed by a Notified Body. A Notified Body is an organisation which has been designated by the government to test and certify the products. DEKRA is a Notified Body and an independent, accredited institute. These services can be combined, but that’s not always necessary.
Is your product in risk class 1? If so, it doesn’t need inspecting by a Notified Body. You can test the product yourself and affix a CE marking on it yourself as well. 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 marking on your product.
Is your product in risk class 2 or higher? In that case, 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 centres. 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.
Benefits of DEKRA
Having medical devices tested and certified by DEKRA Product Testing gives you a number of benefits:
- You can provide a risk class 1 product with a CE marking.
- You can prepare a risk class 2 product (or higher) for certification by a Notified Body.
- You will be issued with test results and certificates by DEKRA, which will be accepted worldwide.
- You will gain the trust of stakeholders on account of independent test results.
All medical devices must first be certified before being sold on the market. DEKRA can test all your electrical medical products, regardless of their risk class. Is your product in risk class 2 or higher? In that case, you can submit our test results to a Notified Body. This Notified Body can be DEKRA, but this doesn’t have to be the case. A Notified Body is not allowed to prioritise products which have previously been tested by them. As such, a Notified Body always works in an objective and independent fashion.