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).
- Since 2019, registration of implants in the Dutch Implant Registry (LIR) is legally required for Dutch Healthcare Providers (hospitals and clinics).
- From 26 May 2021 the hospitals and clinics are required to store and keep record of all class III implantable medical devices, under the Medical Device Registration (MDR). Manufacturers must place/assign a UDI to the medical device and all higher packaging levels.
- It is expected that in 2022, the inclusion list under the LIR will be expanded to include all Class III implants.
Read the letter with the urgent appeal of ZKN, NFU and NVZ to suppliers to really get going now.
With GS1 standards we can help you
With GS1 barcodes and GS1 Data Source Healthcare we can help manufacturers and healthcare providers.
Within the Netherlands the Dutch hospitals are required to register all medical devices mentioned on the inclusion list (appendix 4 of the agreements on unique coding medical devices) as of January 1st 2020 in the Dutch Implant Registry (LIR).
In order for the hospital to comply with the regulation the hospitals and the Dutch Implant Registry need to receive your product data via the Global Data Synchronisation Network (GDSN). If the hospitals and the Dutch implant Registry do not receive the product data, the hospitals will be unable to register your products in the Dutch Implant Registry.
Within the regulation there is no official obligation towards the manufacturer, but without the help of the manufacturer the hospital cannot comply with the regulation. Document GS1 Standards give explanation for suppliers to comply with the requirements of the Dutch Implant Registry (LIR)’.
More information about UDI can be found on the page MDR.
GDSN - GS1 Data Source Healthcare
GS1 Data Source is the Dutch service we offer in order to use the Global Data Synchronisation Network (GDSN) to exchange product data.
We would advise you to connect with a GDSN certified data pool in your country to share your product data with Dutch healthcare institutions and/or other recipients over the world.