Dutch Regulators Plan US FDA-based UDI Requirements for Medical Devices
- Voluntary agreement between Ministry of Health, industry and hospitals
- All devices will have UDI codes
- Only implants with proper UDI codes accepted in The Netherlands starting in July 2018
On June 21, 2017, the Dutch Minister of Health signed an agreement with healthcare providers, manufacturers and distributors of medical devices to introduce an unambiguous identification system for medical devices.
Using the FDA UDI system as a starting point
The main reason for setting up the system (link in Dutch) is the need to be able to identify devices from manufacturer to the patient. This identification needs to cover the device as well as identify its batch or lot number as well as other production characteristics. The Dutch Ministry of Health has taken a very smart step here: They decided to adopt the US Food and Drug Administration’s Unique Device Identification (UDI) outright. By doing so, Dutch regulators do not require an additional code on the device label, which could cause confusion. By choosing the FDA’s UDI system, Dutch regulators are instead promoting the introduction of the FDA UDI system in Europe.
This agreement is not based on a law; it is rather an agreement between all parties involved: Dutch hospitals will all use UDI exclusively for identification and traceability of medical devices, and industry promises to place only UDI codes on device labels. Because both hospitals and manufacturers have agreed, they don’t have to worry about alternative identification techniques or requirements. Of course the recently adopted Medical Devices Regulation 2017/745/EU and the In Vitro Diagnostic Medical Devices Regulation 2017/746/EU introduce UDI in Europe. But the recent agreement in The Netherlands speeds up this process.
Implantable devices first on the UDI compliance list
A secondary effect is that because no other European Member State has taken this bold step yet, the Dutch manage to set the standard for the industry. Every manufacturer that wants their devices used in high-quality, well-funded Dutch hospitals needs to switch to UDI now.
In order to give all parties enough time for this transition, the first step is to make sure all implantable medical devices have a UDI code on their labels by July 1, 2018. For now the data requirements for UDI registration in The Netherlands are the same as those for FDA UDI compliance. However, data requirements may undergo further adaptation as European regulators continue developing UDI components of the EUDAMED database. Dutch authorities currently use GS1 to supply UDI codes for domestic manufacturers, and to support the introduction of this system in hospitals.
Shorter European UDI implementation timeframes?
Once implantable devices have all switched to UDI new groups of devices will be added, until all devices used in Dutch hospitals have UDI codes. Although final introduction of UDI for Class I reusable medical devices will be required on May 26 2027, implementation may occur earlier because of this initiative in The Netherlands.