Under direction of Ministry of Health, Welfare and Sport, branch organisations (Nefemed, FHI, FME, NFU, NVZ and ZKN) signed agreements in 2017 for the unique coding of medical devices and the exchange of article information. The unique coding enables the scanning of barcodes (authorised barcodes GS1-128 and GS1 DataMatrix) in order to trace which medical device was used by which patient.
These agreements are in line with the Dutch Implant Registry (LIR) and the Medical Device Regulation (MDR).
What do these agreements mean?
- Article codes of accredited parties: GS1, HIBC, ICCBBA
- Permitted barcodes: GS1-128 and GS1 Data Matrix
- GS1 Data Source for the exchange of product data
How does this work?
Manufacturers must provide all medical devices on the inclusion list (Annex IV ADC document) with a UDI (Unique Device Identification) and share the corresponding article data with healthcare organisations via GS1 Data Source (GDSN).
Healthcare institutions ensure that medical devices are registered and traced throughout the institution by scanning the barcode - Unique Device Identification (UDI). Additional article data comes from GS1 Data Source.
Procedures for recording which medical device is at which location and which medical device was ultimately used on the patient are included in the agreements.