The distribution of medical devices at an international level, has created the need to install a Unique Device Identification, also called the UDI (Identification Unique des Dispositifs Médicaux in French). Indeed, by improving the traceability of medical devices, the UDI helps to fight counterfeiting and to facilitate product recalls, thus improving patients’ security.
Before regulation was introduced surrounding the UDI, each manufacturer or distributor was able to develop their own mechanism of identification. This absence of harmonization proved to be limiting and even dangerous because of the risk of confusion between the different products, subject to several standards of identification, with their differences and incompatibilities.
Further, with the promotion of the working group made up of authorities who regulate medical devices, such as those in the European Union, the United States, Canada, or Japan (Global Harmonization Task Force on Medical Devices – GHTF), subsequently becoming “International Medical Device Regulators Forum” (IMDRF) in October 2011, new rules have been implemented in the European Union (B) as well as in the United States (C). However, before approaching these different regulations, a reminder of the system in France will be given (A).
A. The system of Unique Device Identification in France
A systematic and unique identification system of medical devices does not exist in France. At the very best, there are some provisions of the French Public Health Code for material vigilance (including articles R.5212.35 and following), which impose obligations of traceability and consequently of identification for certain, albeit of a limited number, medical devices.
In order to make up for the lack of harmonization, in 2006 the French regulatory authority for medical devices, the National Agency for the Safety of Medicine and Health Products (ANSM in French), published some recommendations for manufacturers of medical devices, in order for them to implement a system of codification enabling the unique identification of medical devices. It is however non-binding regulation for manufacturers.
With the growth of interest for a universal identification system, international bodies are working to develop a common international standard.
B. The system of Unique Device Identification in the European Union
Following the IMDRF’s work, the European Commission issued a recommendation (2013/172/EU) the 5th April 2013, aimed to “facilitate the compatibility of the traceability mechanisms established at national and/or regional level and to pave the way to the mandatory implementation of an internationally compatible UDI system of the Union” (introduction – point n°5).
The UDI consists of a digital or unique alphanumeric code, created according to an identification standard and an international codification involving two identifiers:
- Device identifier: unique to the manufacturer and to the medical device model; it is said to be “static”, i.e. identical for a same medical device;
- Production identifier: helps to identify the production unit of the device and the information related to its production, to the batch and to the expiry date; this is considered to be dynamic information, depending on the mode of control of the manufacturing process.
The identifiers must appear clearly in the form of encrypted data, for example through barcodes.
The implementation of the UDI would be combined with obligations for the different parties involved in the distribution of medical devices:
- Manufacturers: they have to assign an UDI to the medical device, conforming to international standards, affix it at each packing level of the medical device and provide the required information on the UDI in order to input to the database on medical devices (Eudamed for European Databank on Medical Devices);
- Importers and distributors: they have to verify the UDI attributed by the manufacturers and register it in their own information system, as well as the references of the device’s purchaser. The importers must also ensure that the UDI is registered in Eudamed;
- Health institutions: they have to register the product’s UDI and be able to establish, for certain types of medical devices, a link between the device used and the patient.
The European legislation concerning the UDI, being only a recommendation, is not binding for the Member States, and is only intended to encourage them to implement the recommended rules. However, in the future the proposal for a European Parliament and Council Regulation concerning medical devices will include provisions concerning the UDI which will render them compulsory.
This system of European recommendation, even though optional, is intended to be applied in France for all medical devices and is to be considered as a substitute for previous recommendations.
According to the ASNM, the SNITEM, the main union for manufacturers of medical devices in France, has suggested launching a testing phase of the use of the UDI by its members.
For their part, the United States are a step ahead of the European Union and have imposed a mandatory system of identification, which will soon be applicable.
C. The system of Unique Device Identification in the United States
The Food and Drug Administration (FDA) has regulated the identification of medical devices sold on its territory. From the 24th of September 2014, the Class III medical devices will have to carry a unique identification number; then progressively, according to their class and their nature, the other medical devices will also fall under this new rule. After September 2020, all medical devices will be included in the unique identification system. All of these rules relating to the identification of medical devices are available on the FDA website.
The choice of identification number will operate through a system of international standards for all of the health products’ supply chain. The FDA has indeed just accredited an agency, the GS1, to release the UDI.
Therefore, all manufacturers of medical devices, French or European, who export to the United States will be subject to American legislation on exported goods concerning identification rules. Fortunately, thanks to work done at an international level on the UDI, the compatibility of the identification system is assured in order to avoid that the manufacturers have to pay excessive additional costs, whereas we know that the implementation of the UDI regulation will be expensive for all involved.