Medical Devices Regulatory Services
in Italy

Overview

With a growing demand for Medical Devices, Italy stands as one of the largest Medical Devices market in Europe. 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.

Regulatory Authority: Directorate General for Medical Devices and Pharmaceutical Service of MoH

Regulation: Medical Device Regulations, 2017

Regulatory Pathway: CE marking followed by Notification

Authorized Representative: European Authorized Representative (EAR) for Non-EU manufacturers

QMS Requirement: ISO 13485:2016

Assessment of Technical Data:  Notified Body for CE marking

Validity of License: Unlimited

Submission Format: Paper

Italy Medical Device Classification

Prior to marketing the Medical Devices, either Active Implantable Medical Devices (AIMD) or In-vitro Diagnostic Medical Devices (IVDDM), it is mandatory for the manufacturers to obtain CE certification. In order to obtain the CE marking, the market entrant must submit the devices to compliance evaluation with the essential requirements described in the applicable European directives. These European provisions have been transposed into French law in the Public Health Code.

European Authorized Representative (EAR) Services

Manufacturers based out of European Union shall appoint a European Authorized Representative (EAR) to market the devices in any of the EU member countries. The EAR appointed shall comply with all requirements defined in Medical Device Regulations (EU) 2017/745.

Italy Medical Device Registration

With no online registration system, application forms along with required documents must be submitted to the MoH via email or by post/hand delivery. 

Process flow

Post Approval Device Life Cycle Management

Freyr supports the foreign manufacturers in end-to-end Medical Device lifecycle Management, including post approval activities, such as:

  • Post approval change management - modifications to existing medical device approvals such as, addition of new variants, accessories; addition of new indications of use among others
  • Maintenance of ISO 13485:2016 and CE certification
  • Renewal of licenses
  • Liaising between the Notified body and the manufacturer

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.

Summary

Type of Device Risk QMS Audit CE Marking Regulatory Pathway

Class I

Low Risk

N/A

CE Self-Certification

Registration

Class IIa

Low- Moderate Risk

ISO 13485:2016 certification

CE Mark

Notification

Class IIb

Moderate - High Risk

ISO 13485:2016 certification

CE Mark

Notification

Class III

High risk

ISO 13485:2016 certification

CE Mark

Notification

Expertise

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 consultation
  • Medical Device Regulatory strategy report
  • Testing support- biocompatibility, electrical safety, mechanical and performance
  • Labeling and GMP support
  • Post-market monitoring and Adverse Event reporting
  • European Authorized Representative support