Medical technology medical device testing
DEKRA Product Testing

DEKRA Notified Body & Medical device testing

Testing and certification of medical technology

The safety and quality of medical devices are becoming increasingly important. Innovations, likewise, are evolving at an unprecedented pace. To an increasing extent, medical devices are integrating more software and wireless connections. All these developments mean that manufacturers of this medical devices, as well as test centres, are having to meet an ever growing number of requirements. DEKRA Product Testing can test and certify your medical devices. We have more than 25 years’ experience in this field and can call on an extensive network of medical experts.
Rapid developments in the medical market have led to more stringent statutory regulations being introduced, especially when it comes to clinical studies. DEKRA can fall back on comprehensive specialist know-how when assessing these studies. We have all the necessary in-house expertise for evaluating your medical devices. What’s more, all of our activities put the safety of patients firmly centre stage.
Trends & Developments
More rigorous patient safety

With the increased focus on patient safety, regulations covering medical aids have become more rigorous.

Cyber security

Cyber security is becoming increasingly important given the expanding role of software in medical equipment. And more than ever, these devices are being linked to each other via (wireless) connections.

Regulations and guidelines

The relevant authorities at national, European and worldwide level are endeavouring to harmonise regulations and guidelines.

Safe electric medical devices

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.

Find out more about our testing and certification services for medical devices

Declaration of impartiality
We apply high standards, especially to ourselves
The DEKRA Certification B.V. top management declares the following commitment to impartiality: Our guiding principle is to fulfill and actively live the values which we look for at our customers. Only thus can we perform credibly as a service provider and role model with a customer-oriented approach. The basis for this is provided by our own management system and highest transparency internally and externally.
With the decisions they take in their daily activity, all the employees of DEKRA, including the Management Board, executives and staff, follow the principles of impartiality, objectivity and integrity.
- Bram Holtus, Managing Director