Overview

The European medical device market is considered as the second largest after the USA, and emerging markets like Germany, France, Italy, UK and Spain. Being a manufacturing hub for medical devices such as orthopedic, consumables, respiratory, dental, and ophthalmic devices, the Europe medical device market offers good opportunities to new market entrants but with the caution of cut-throat competition and complex, geographically distributed regulations.

Freyr has strong presence in the European market with local affiliates as well as an exclusive delivery center in the United Kingdom (UK). Freyr covers the entire spectrum of Regulatory support services for medical devices in order to market products in these stringently regulated countrie

 

Freyr Expertise

  • Product Assessment & Classification
  • Impact Assessment and Gap Analysis
  • Gap Analysis of the Technical documents & Quality systems
  • Regulatory support for product development documents such as Design History files
  • Regulatory support for Technical File Preparation, Submission – CE Applications
  • European Medical Device Regulation - EU MDR Support
  • Comprehensive EU MDR Support & transition consulting
  • Product classification and registration services
  • CE Marking and ISO 13485 compliance
  • Label compliance services
  • Guidance for Implementation of Unique Device Identification (UDI)
  • Global Regulatory Impact Analysis
  • Regulatory and market intelligence support
  • Authorized representative services
  • Health Agency liaising and support
 

Freyr Advantages

  • Successful submissions for varied class of devices ranging from software to sutures
  • Local affiliate access to meet challenges of authority and language specific requirements
  • 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