The healthcare sector is currently facing increasing complexity in terms of regulations and reporting obligations, including:
- MDR/IVDR: with strict requirements regarding product identification, UDI and master data
- EUDAMED: as the central European registry for medical devices and IVDs.
ECHO (Extending the Collaboration of Healthcare Organisations) is a European GS1 initiative that aims to harmonise data requirements in healthcare across borders and translate them into one common data model.
Reduces administrative burden
Strengthens the digitalisation of healthcare in Europe
Enables cross-border data exchange
GS1 Belgium & Luxembourg is the neutral data governance partner, supporting Belgian and Luxembourg stakeholders in the practical implementation of ECHO, taking into account EUDAMED and MDR/IVDR regulations.
Through ECHO, GS1 Belgium & Luxembourg supports:
- Manufacturers in structuring master data in line with MDR/IVDR and EUDAMED;
- Hospitals, logistics partners and other stakeholders in receiving consistent, validated product information;
- Authorities and sector organisations by contributing to interoperable and future-oriented data exchange.
What does this mean in practice?
For GS1 Belgium & Luxembourg, ECHO is a strategic building block in supporting Belgian and Luxembourg stakeholders across the entire healthcare chain in their transition towards harmonised, reliable and reusable product data, in line with European regulations and international GS1 standards.
There is an ECHO working group with representatives from various European countries, within which agreements are made on which product data is exchanged via GS1 Global Data Synchronisation Network (GDSN).
A uniform dataset
The ECHO data model brings together all requirements in one dataset, based on GS1 standards (such as GTIN, UDI and the use of GS1 GDSN). This allows companies to manage product data correctly once and reuse it for both operational processes and regulatory reporting.
In the ECHO data model, you will find an overview of the information required per country and per regulation, as well as which data must be entered in which field (mandatory), etc.
Indeed, requirements for providing product information differ from one country to another, for example in terms of language and applicable legislation. This leads to fragmentation, manual processes and an increased risk of errors in product data management.
Enable international growth
- Align product data across countries
- Use a common semantic data model
- GS1 GDSN as a neutral, standardised infrastructure for data exchange.
Download the current data model here
You will find an explanation of how and where to enter the item data.