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European medical device directive

Sep 17, 2024

Everything you need to know

When it comes to medical devices, safety and quality are paramount. Therefore, stringent legal requirements are in place within the European Union. Since 2017, these requirements have been tightened with the introduction of two new European directives: the Medical Device Regulation (MDR 2017/745) and the In-Vitro Diagnostic Regulation (IVDR 2017/746).

The MDR (Medical Device Regulation) covers a wide range of medical technology, from catheters and pacemakers to advanced CT scanners. This directive ensures that all products meet the highest standards in terms of safety and performance.
The IVDR specifically targets In-Vitro diagnostics (IVDs), such as pregnancy tests and blood group tests. Although IVDs also fall under the broad category of medical devices, their specific nature necessitates a separate set of rules.
These new European directives for medical devices replace the old regulations. The focus of the new regulations is on the following aspects:
  • Better clinical performance
  • Improved traceability of medical devices
  • Increased transparency for patients
The common goal of the MDR and IVDR is to better protect public health and patient safety. Medical devices must comply with the MDR since 2021. Since 2022, this also applies to IVDs.

CE marking for medical devices

Do you want to market medical devices as a manufacturer? Then you need CE marking. This marking shows that your products meet the legally established requirements. The exact requirements depend on the medical device.
In the European directives, medical devices and IVDs are divided into several risk classes. The higher the risks during the use of a device, the higher the risk class and the stricter the requirements.
For devices in a low-risk class (Class I under the MDR or Class A under the IVDR), you as a manufacturer can determine yourself that your product meets all requirements and register the device with the authorities.
Do your medical devices fall into a higher risk class? Then you need a Notified Body to assess your products. A Notified Body is a certifying institution designated by the government for product inspection. DEKRA has been a Notified Body for over 25 years. We assess whether the product is safe and meets all requirements. If so, you receive CE marking and can market it in Europe.

Quality management with ISO 13485

In addition to CE marking, there is ISO 13485. This international standard for the quality management system for medical devices is intended to help manufacturers and suppliers comply with legal requirements and customer needs. The goal is to ensure the safety of medical devices and minimize risks for patients.
Customers increasingly see this certification as the basis for CE marking. ISO 13485 is not a mandatory European directive for medical devices. However, to meet the requirements for CE marking, a quality management system according to European directives must be present in the organization. DEKRA is also authorized to assess whether you comply with ISO 13485 and to grant the corresponding certificate.

Complying with the European medical device directive with DEKRA

At DEKRA, we are happy to use our experience as a Notified Body to certify your medical devices. This demonstrates that your products comply with the European Medical Device Directive. Feel free to contact us for more information.
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