Overview

Netherlands is one of the major medical device markets in Europe accounting to 3-4 % of market share. The Health Care Inspectorate (Inspectie voor Gezondheidszorg or IGZ) of Dutch Ministry of Health is responsible for implementing the Dutch Medical Devices Act in Netherlands. To market the medical devices in Netherlands, manufacturers are required to perform a CE certification conformity assessment, prepare a technical file, and draw up the conformity declaration. In addition, they must apply for the CE marking for the product, as per the EU rules and regulations. They can apply for approval either through registration or notification basing on the classification.

Decoding Regulatory information pertaining to device registration or notification through Notis online registration system can prove challenging without an expert’s assistance. Moreover, given the specialized instructions in place for different classes, identifying the right class of device is crucial in determining the Regulatory pathway.

To obtain a CE marking successfully, Freyr assists in adhering the conformity requirements needed. Further our experts support in device classification, technical file compilation, online registration and all other Regulatory processes so as to navigate the pathway compliantly and make a successful registration.

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
  • Notification/Registration of Medical devices through Notis online registration system
  • 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
  • Access to local affiliates
  • Dedicated personnel to provide Medical Device and IVD Regulatory support
  • In-country or legal representative support with a cost-effective model