The main objective of the Unique Device Identification (UDI) legislation is to increase patient safety. The second objective is to allow better traceability of medical devices. All devices have to be in the European Database for medical devices: EUDAMED. The UDI legislation is part of the new Medical Device Regulations (MDR). The MDR directive will be in place from 2020, giving manufacturers and other parties involved the time to adapt. This is planned by the EU to be live on the 26th of March 2020.
These UDI codes consist of two parts. The first part identifies information such as country of origin, manufacturer and type of product. The second part is more specific to the individual product including expiration date, lot and batch number. The UDI regulations for high risk devices need to be implemented one year after legislation starts, by May 2021. These high risk medical devices are the class III devices, such as breast implants and pacemakers.
Although there a multiple reasons for this shift in regulation, an important part of it is the PIP breast implant scandal. Over the course of several years, the material of the breast implants used by certain surgeons changed, with severe damage to patients as a result. The new regulations should make it easier to track implants and its materials, and create a safer process overall.
Class III devices
With the new legislation, hospitals need to report incidents with implants to the appropriate national institute for drug and medical devices. Furthermore, health institutions must store and keep certain records. These preferably electronic records have to be kept of the devices they have supplied, or with which they have been supplied. This is applicable only if those devices belong to the class III implantable devices. In addition, hospitals have to hand out an “implant-pass” to the patient. For other medical devices (not class III), it is not obligatory for hospitals to store Unique Device Indicators electronically, but it is preferable.
How to manage implants?
Implants are not necessarily managed by the (hospital) pharmacy. For instance, doctors and the purchasing department can also directly manage the implants. Doctors and the hospital purchasing department can decide which implant, from which manufacturer to prescribe. Depending on the hospital’s internal policy, the implant can go through the hospital pharmacy. Alternatively, it can go directly from the hospital purchasing department to the doctor using the implant. Figure 1 shows the two possible paths of an implant. The choice of internal policy is up to the hospital. In both cases, the booking and registering of the implant would be performed by the receiving party.
Possible paths of an implant:
Figure 1: Possible paths of an implant
How is Germany dealing with the UDI-codes for medical devices? In Germany, the so-called “benannte Stellen” (notified bodies) will give out the UDI-codes for medical devices. Currently, these bodies are not yet able to handle the estimated number of requests for UDI numbers. Eventually this will result in a bottle-neck situation. This will cause problems for manufacturers selling medical devices in Germany, and the rest of Europe.
A study conducted by McKinsey among German hospitals shows that in general, the financing for these digital initiatives is not sufficient yet. The expectancy is that this would also apply to solutions for implementing the MDR directives. An additional concern is that the supply chain management can become an issue. Especially for smaller hospitals it could become difficult to have the correct infrastructure in place in time to meet deadlines. In general, every country will have their own way of dealing with the new directives. One thing is for certain: it will bring change to the whole medical system.
As an international medical manufacturer, this might affect your plans for expansion. We’re here to help. If you require more information about the unique device identification, please get in touch with our VP Healthcare: Emre Aykac. For more information about our services, click here.