Service features

Consultancy on CE marking for medical devices

We provide consultancy on MDR-compliant CE marking for new medical devices and approval for modifications to products with existing markings. We also manage the relationship with notified bodies.

Context and introduction

Medical devices can circulate freely in the European Union when CE marking is applied to devices. Securing CE marking requires conformity with the 2017/745 medical device regulation (MDR) and the relevant harmonised standards.
The aim of the medical device regulation is to ensure the manufacturer provides evidence of compliance with general safety and performance requirements laid out by the regulation.

01

Quality system

We develop a quality system based on ISO 13485 for companies that manage medical devices, which also ensures conformity with the 2017/745 medical device regulation (MDR).
In addition, we provide on-site support for certification and monitoring audit from the competent authority.

02

Technical file

We develop the technical file for the certification of class I and class I sterile medical devices (electromedical and non-electromedical), including those with measuring functions and those that are reusable, as well as class IIa, IIb and III devices; based on the 2017/745 medical device regulation (MDR) and harmonised standards.

03

Eudamed registration and UDI

We manage the registration of manufacturers, importers, distributors and medical devices on to the Eudamed database. We also secure and support the use of the UDI code (UDI-DI, UDI-PI and basic UDI).

04

Training courses

In addition to consultancy for CE marking of medical devices, we also deliver approved training courses on European and Italian regulation in the medical industry.

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