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DG Internal Market, Industry, Entrepreneurship and SMEs

Guidelines for Member States on the use of

Data Exchange solutions

MDR EUDAMED

Date: 18/04/2019
Doc. Version: 1.0
Guidelines on Data Exchange solution

Document history:

Revision Date Created by Short Description of Changes

1.0 18-04-2019 Silvia García Díez Created document

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Contents

1 INTRODUCTION 4
1.1 Purpose .................................................................................................................... 4
1.2 Requirements for the different modes of data input................................................... 4
1.3 Assessment for Competent Authorities for Actors and Certificates data ...................... 6
1.4 Assessment for Economic Operators for UDI and Basic-UDI data ................................. 7
1.5 Assessment for Notified Bodies for Certificates data .................................................. 8

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1 INTRODUCTION

1.1 Purpose

The purpose of this document is to help Competent Authorities, Notified Bodies, as well as all Economical Operators
(Manufacturers, Authorised Representatives, Importers, and System/Procedure Pack Producers) in assessing the most
cost-efficient solution for their needs to comply with the Medical Devies Regulation.

Although Eudamed offers multiple ways of inputting/downloading data, there are several parameters to take into
consideration before making a decision. The different entry points include:
1. The User Interface: this option implies manual input of data through the application.
2. The XML upload/download: this option is a semi-automated one, where the data can be uploaded by means
of XML files. The XML data must be validated agains the provided EUDAMED DTX service and entity model
XSDs. The generation of the files can be automated, but the action of uploading/downloading the files
remains manual.
3. The Data Exchange Machine – to – Machine (M2M) system: this option allows for automatic data exchange
between an external backend system and Eudamed backend services (in bulk as well). The End User enters
information in the external system, and the data is automatically transmitted to Eudamed, in XML format
following the same conditions as previously mentioned without any human intervention. However, the
connection of two systems in a fully automatic way may be too costly considering many architectural,
technological and operational aspects (e.g. local application readiness, interoperability, infrastructure,
security, support, etc.) if the frequency and/or volume of transmission remains low.

This document covers only the assessment on data related to Actors, UDI, and Certificates module. It will include
Vigilance and Clinical Investigations at a later stage.

The Security requirements mentioned in Section 1.2 will be published at a later stage.

1.2 Requirements for the different modes of data input

We provide here, a brief description of the requirements for the three already mentioned data input methods:

The User Interface

This option is the simplest one from data handling / manipulation / implementation point of view. The User only
needs a PC with Internet connection and a browser to connect to Eudamed.

The XML upload/download trough EUDAMED UI

In addition to the requirements to connect to Eudamed, the User will need to provide (upload) the data in XML format
to Eudamed. This will allow bulk upload of existing information by uploading the XML files through the User Interface.
It is advisable to produce the XML format data in an automatic way to avoid validation errors of the data. Some
implementation effort by an IT team will be required taking into consideration the complexity of the data format
(XSDs) and validation rules (e.g. field sizes, tags positions, mandatory / vs. not mandatory, etc.).

Similarly, the User will only be able to bulk download the data in XML format. This format, although understandable,
is not easy to be read. A software that displays this information in a more readable structure should be considered.

This solution could be useful when Eudamed goes live, where a high volume of data needs to be input, but where
subsequent updates can be done through the User Interface. In this situation, the set up of a data exchange
connection would not be justified, as it would be a one-off upload.

The Data Exchange

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In this case, the data will be automatically transmitted between an external system and Eudamed. To achieve this, the
external system must be extended in order to convert its data into the XML format requested by Eudamed DTX and
implement a specifi data exchange protocol.

Furthermore, in order to establish the connection through eDelivery, there is a need to link the external system with
an Access Point. This Access Point needs to be installed on specific hardware on premises, and maintained (support,
versions updates, configuration, etc.).

Because this mechanism allows bulk download of sensitive data in a fast way, the application connected to Eudamed
will also need to comply with a series of security requirements, in order to preserve the defined security level.

The data exchange may be updated in future releases, e.g., when there is a new field, or a new value of a label, or a
new functionality. Whenever there is a new release, all systems connected through the data exchange system will
have a 6 months period to be updated in order to adapt to the new changes.

Overall, this is the most complex and costly solution, which should only be considered under the following conditions:
- the amount of data to be uploaded/downloaded cannot be entered manually
- there will be frequent exchanges of information between systems
- the cost of manual input outweights the cost of automation
- there are available resources for implementation and maintenance

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1.3 Assessment for Economic Operators for UDI and Basic-UDI

data
Yo u are an
Yo u are a System/
Authorised Representative You are a Manufacturer
Procedure Pack Producer
or Importer

Do you have your

own internal System with all
available data?

What do you need?

Submit or donwload information

on UDI, BASIC-UDI, and device data

How many Devices

do you have to register/ > 1000
download?

At what frequency will

you register / download the
devices?

< 100
High frequency
> 100 and < 1000

Low or medium Do you intend to

install and maintain a Data
frequency Exchange solution?

NO YES

Do you intend to install

and maintain yo ur own
Access Point?

YES
NO

Use XML upload/

Use Eudamed User download through Use Data Exchange with Use Data Exchange with
Interface Eudamed User own Access Point Third Party Access Point
Interface

Installation and maintenance of Data Exchange with own Installation and maintenance of Data Exchange with a Third
Access Point implies: Party Access Point implies:
• Cost of infrastructure (hardware) • Cost of infrastructure (hardware)
• Cost of adaptation of existing data to the Eudamed • Cost of adaptation of existing data to the Eudamed
Use of the XML upload/download implies:
structure (XSD) done by an IT team structure (XSD) done by an IT team
• Cost of adaptation of the existing data to the Eudamed
• Cost of setting up of an Access Point • Cost of use of a Third Party Provider’s Access Point
structure (XSD)
• Cost of updating the required software when a new • Cost of updating the required software when a new
version of Eudamed’s Data Exchange is available within version of Eudamed’s Data Exchange is available within
a period of 6 months a period of 6 months
• Compliance with defined Secu rity Measures • Compliance with defined Security Measures

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1.4 Assessment for Notified Bodies for Certificates data

You are a Notified Body

What do you need?

Import Certificate information

Do you have your

own internal System with all YES
available data?

Do you intend to
install and maintain a Data
Exchange solution?
NO

YES

Do you intend to install

and maintain your own
Access Point?

YES
NO

Use Eudamed User Use Data Exchange with Use Data Exchange with
Interface own Access Point Third Party Access Point

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