Medical Device Regulatory Services
in Europe


The European region is considered the second largest market, after the US, for medical devices. At the same time, Europe has a very complex and stringent regulatory compliance. From the implementation of MDR, Brexit to Swixit, Europe has experienced volatility in terms of regulations, especially for medical devices.

Freyr has a strong presence in the European market with established delivery centers in Germany, UK, and Switzerland. Freyr covers the entire spectrum of Regulatory support for Medical Devices to market products in these stringently regulated countries. 



Freyr Expertise

Freyr Advantages


Freyr Advantages


Successful submissions for varied class of devices ranging from simple Class I devices to complex devices such as, Class III devices, Implants, SaMDs


Local affiliate access to meet challenges of authority and language specific requirements


Dedicated Medical Writing team for CE projects


Dedicated personnel to provide Medical Device and IVD Regulatory support


In-country or legal representative support with a cost-effective model


Exclusive delivery center in the UK