Medical device – class I

Mediator can help with application to the Danish Medicines Agency, risk assessment and CE declaration of conformity. The application naturally complies with all aspects of the main directive (EU) 2017/745 adapted to Danish executive order, BEK no. 837 of 20/06/2023 – Executive Order on medical devices etc.

We also review and assess labels and claims – and review your website if you have a webshop. We assess whether the product is covered by the rules for medical devices, class I or other legislation, e.g. the Biocidal Products Regulation.

Data will be compared with your clinical studies. We can also assist with guidance for market surveillance.

If you would like to know more about how we can help you, please feel free to contact us by phone.
75 54 08 24 or email info@mediator.as to hear more.