Overview

With a growing demand for comprehensive medical devices, Italy stands as one of the largest medical devices market in Europe. The Directorate General for Medical Devices and Pharmaceutical Service of Ministry of Health is the competent authority responsible for regulating the import, marketing and trade of medical devices in the country. As a mandate, all Medical Devices must be registered with the Ministry of Health prior to their market entry, to obtain which, they must perform a CE certification conformity assessment submitting relevant technical documents. With no online registration system, application forms along with required documents must be submitted to Ministry of health via email or by post/ hand delivery.  

Obtaining a CE Certification could prove challenging since it is a long process involving compilation of numerous documents as specified by the EU device laws. Freyr offers end-to-end Regulatory services for Medical Devices and authoritative Regulatory intelligence to decode the peculiar requirements and supports in dossier compilation for compliant submission. 

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 with Italy – Ministry of Health
  • Registration of Foreign Medical Device Manufacturers in Italy
  • 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
  • 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