Comply with the new regulations regarding medical devices

As of May 26th 2020 the European Medical Device Regulation (MDR) will be implemented, followed by the In Vitro Diagnostic Regulation (IVDR) on May 26th 2022. These new regulations have consequences for manufacturers, importers and distributors of medical devices as the new regulations apply to all medical instruments, and also have their effect on healthcare institutions, healthcare providers and (indirectly) on patients.

Manufacturers and suppliers of medical instruments amongst others need to make sure that all products can be identified with a unique device identifier (UDI) and CE-certificate. Only when medical instruments comply with the legal requirements, they can be sold on the European market. This blog explains how GS1 and SRC-PIM help you to conform with these new regulations.

GS1 helps you identify products with GTIN

All medical appliances should be registered in the European database Eudamed before the 26th of May 2020 (26th of May 2022 for IVD appliances). To register in Eudamed, you will need to enter Single Registration Numbers (SRN) for each product. Moreover, healthcare institutions and healthcare providers in the Netherlands need to register the UDI’s (GTIN) of all class III implants linked to a patient in the National Implants Register (Dutch: LIR – Landelijk Implantaten Register). GS1 has been designated by the European Commission as issuing entity for UDI’s. This means GS1 can issue Global Trade Item Numbers (GTIN) which you can add as a UDI to your medical products.

Publish your data to the GS1 Data Source Healthcare with SRC-PIM

The healthcare sector in the Netherlands uses the GS1 standard. With the GS1 Data Source Healthcare, GS1 offers a central datapool for exchanging product data and ensures users that their data comply with (inter)national laws and regulations such as MDR and IVDR.

As a manufacturer or supplier of medical instruments, you will likely need to publish product information to GS1 to make it available for healthcare institutions and providers. As a healthcare institution and provider, you will need to extract data from the GS1 Data Source Healthcare to complete patient’s electronic health records. But how can you do this? You could do this manually using the GS1 platform. However, as the process through the GS1 platform is performed by hand, thus taking lots of time and increasing the possibility of making mistakes, companies are often making use of a PIM system such as SRC-PIM. SRC-PIM ensures that product information is validated and up-to-date with the GS1 standard. Moreover, due to the integration with GS1, product data are published directly to the GS1 data pool.   

Learn more about GS1 and SRC-PIM

Make sure the correct data are published to GS1 Data Source HealthcareRead our free whitepaper and discover how you can manage and publish your data according to the GS1 standard.