Medical Device Regulatory Services
in The European Union

Overview

The European Medical Device market is considered second largest after the U.S. market with Germany, France, Italy, UK and Spain emerging as the most promising markets. Being a manufacturing hub for Medical Devices such as, orthopedic, consumables, respiratory, dental, and ophthalmic devices, the European Union Medical Device market offers good opportunities to new market entrants, but with the caution of cut-throat competition and complex, geographically distributed regulations. Recent Brexit of UK from the European Union (EU) has left an unprecedent impact on Medical Device industry. 

Freyr has strong presence in the European market with local affiliates as well as an exclusive delivery center in the UK. Freyr covers the entire spectrum of Regulatory support for Medical Devices in order to market products in these stringently regulated countries. Our services include:

  • Product Assessment & Classification
  • Impact Assessment and Gap Analysis
  • Technical File (TCF) updating and conversion 
  • Label compliance services
  • Guide for implementation of EUDAMED
  • Global Regulatory impact analysis
     
Expertise

Freyr Expertise

  • Regulatory strategy for transition of existing CE Marked Devices to comply with new EU MDR and IVDR Regulations
  • Product Classification and Registration services 
  • ISO 13485:2016 Compliance and Certification
  • MDSAP Compliance and Certification
  • European Authorized Representative (EAR) services in compliance with EU MDR Regulations
  • Remediation and action plan for Brexit transition
  • UK Responsible Person
  • Comprehensive European Medical Device Regulation (EU-MDR) Compliance & Transition consulting
  • Gap Analysis of technical documents & quality systems
  • Regulatory support for product development documents such as, design history files
  • Regulatory support for Technical File Compilation [CE Technical File]
  • Regulatory and Market Intelligence support
  • Health Agency and Notified Body liaising and support
  • End-to-end project management for EU MDR, IVDR and post- Brexit transition
  • EUDAMED Compliance
Freyr Advantages

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