Overview

Germany, with high industrial standards for manufacturing medical devices, is the most sought-after market for device manufacturers. Devices marketed in Germany must procure a CE mark and ISO 13485 certification. Technischer Überwachungsverein (TUV) aka Technical Inspection Association, Deutsche Gesellschaft zur Zertifizierung von Managementsystemen (DQS), Deutscher Kraftfahrzeug-Überwachungs-Verein (DEKRA) and Société Générale de Surveillance (SGS) aka General Society of Surveillance are some of the recognized notified bodies which have the authority to certify medical devices. 

With various authorities involved, foreign manufacturers need to comply with multiple set of regulations in each individual process towards device approvals. The clinical testing and validation must be done by EU-recognized facilities such as Federal Institute for Drugs and Medical Devices, and Paul Ehrlich Institute. At times, without a proven Regulatory partner, navigating through all the device requirements might be challenging for market entrants. To assist manufacturers, Freyr provides end-to-end Regulatory services to expedite approvals for medical devices for the types of:

  • Medical Devices- Class I, IIa, IIb & III
  • In-vitro Diagnostics
  • Invasive & Non-invasive Devices
  • Active Medical Devices
  • Special Rule Devices (including contraceptive, disinfectant, and radiological diagnostic)

 

Germany Market Entry for Medical Devices - Process Flow

Germany Medical Devices Regulatory Services

 

 

Freyr Expertise

  • European Medical Device Classification
  • ISO 13485 Compliance
  • CE Technical File or Design Dossier Review, Compilation and Submission
  • EU-MDR Transition and Support
  • Clinical Evaluation Reports (CER) for Medical Devices
  • ISO 14971 Risk Management Consulting
  • Medical Device Regulatory Strategy Report
  • Testing Support- Biocompatibility, Electrical Safety and Mechanical & Performance
  • Labeling and GMP Support
  • Post-market Monitoring and Adverse Event Reporting
  • European Authorized Representative Support

 

Freyr Advantages

  • Successful submissions for varied class of devices ranging from software to sutures
  • Local affiliate access
  • Dedicated personnel to provide Medical Device and IVD Regulatory support
  • In-country or legal representative support with a cost-effective model
  • Exclusive delivery centre in Germany