Medical Device Regulatory Services in Europe

Freyr offers top-notch Regulatory support for medical device registration in Europe, a crucial market with intricate and rigorous regulations in place. With established offices in Germany, the United Kingdom (UK), and Switzerland, Freyr aids in navigating Regulatory hurdles and ensuring adherence to compliance standards.

Medical Device Regulatory Services in Europe Overview

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’s Medical Device Device Registration Services

Medical Device Regulatory Services in Europe

  • 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