Do you work with medical devices?
Do you work using medical devices? Our worldwide standards comply with the national and international requirements listed below and help manufacturers and care institutions and observe these.
Check our overview with deadlines (inter)national laws and regulations for medical device manufacturers.
Registering products in the Dutch Implant Registry (LIR)
In order to trace implants in a fast and efficient way, an automated registration of all implants is required. That is why the Ministry of Health, Welfare and Sport has commisioned the development of the Dutch Implant Registry, also called Landelijk Implantatenregister (LIR).
As of January 1st 2019, the registration of implants in the Dutch Implant Registry is legally required. From 26 May 2020 it applies to all class III medical devices, manufacturers must be provided the medical devices with a UDI.
With GS1 standards we can help you
With GS1 barcodes and GS1 Data Source Healthcare we can help manufacturers and healthcare providers.
According to the Dutch Implant Registry, manufacturers supply article data via GS1 Data Source Healthcare, such as: the article code, product name and additional classifications. Healthcare institutions receive this data via GS1 Data Source Healthcare.
More information for manufacturers is available in the explanation below.