Steps To Selling In The EU

Written by: Maria Duguine

With all the changes in European Union regulations, having a regulatory strategy is the first step to marketing medical devices in Europe. Today, it requires not only knowing if the device is a medical device or in-vitro diagnostic and its classification, but also knowing if it already has a previous CE marking, if it can be part of the grace periods, and even when they have them to plan sales and stay in the US for a long term. All of this is not easy, because day by day the rules in the US are changing. Staying up to date is crucial.

Our EU Authorized Rep, Maria Duguine, prepared the basic steps you need to do registering your devices in the EU.

Step 1: Obtain your CE mark

Manufacturers need to obtain CE marking for all medical devices and IVDs before the products can be sold in the EU. This process includes generating a Technical Documentation and quality management system (QMS) based on the requirements of the MDR/IVDR. The Technical Documentation is comprised by the following documents:

-        Technical File

-        Clinical Evaluation Plan

-        Clinical Evaluation Report

o   Bibliographic search (protocol, execution and report)

o   Clinical investigations, if needed

-        Post-marketing surveillance plan and report

-        Post-marketing clinical follow up (PMCF)

Step 2: Appoint EU Authorized Representative (EC-REP)

Non EU-Manufacturers must appoint an EU Authorised Representative (AR). Under the MDR and IVDR, the EU AR shares liability with the manufacturer for the product on the market and therefore plays a critical role.

The EU Authorized Representative information must be part of the device label and Declaration of Conformity. 

Step 3: Register Company and Devices

Your company and devices must be registered in the EUDAMED database and in the local Health Authority. The registration must be done by the EU Authorized Representative.

Step 4: Appoint an Importer

For selling your devices in the EU, it is mandatory to have an importer when you are not a EU-manufacturer. Importers shall be identified in the medical devices documentation and in the Device Registration. Your EU Authorized Representative must guide you on how to obtain the correct importer.

Would you like to have a training on MDR for your company or need an EU Authorized Rep? Contact us!

Greetings from the EU!