Medical devices

The GCP unit's website is developed for clinical trials with medicinal products, and for clarity reasons the terminology hereof is used throughout the website.

Within clinical trials with medical devices other concepts are generally used, as mentioned here:  

  • trial is called clinical investigation 
  • protocol is called clinical investigation plan
  • standard DS/EN ISO 14 155 shall be applied (is a counterpart to ICH-GCP)

  

When the website refers to GCP, reference is also made to ISO 14 155

Under the individual areas on the entire website, the rules that are applicable to medical devices are added. 

Please refer to the homepage for the GCP Units.

You can see more information on Medical devices on the DKMA homepage here. 

Prices for monitoring trials with Medical devices are the same as for clinical trials with medicinal products, please see here.