In recent years, new European legislation on traceability of medicinal products and medical devices was introduced to guarantee patients’ safety and to avoid fraud. Depending on the industry in which you work, you might have heard more of either Serialisation or UDI (Unique Device Identification). Below we will mention the difference between them. Although the terminology is somewhat different for medicinal Products and for medical devices, in both cases, this is about traceability. And to be precise, it is about track (where the product is now) and trace (where the product came from).
In this blog, we will explain why we advise you - as a medical devices supplier, a medicines supplier or as a logistics service provider - not to wait much longer and start implementing unique identification to take advantage of traceability.
The benefits of traceability
Legislation is not the only reason to implement unique device identification. Traceability has a significant impact on the efficiency of your own and your customers’ operational processes. Traceability is actually nothing new. In many other industries, logistical efficiency is crucial and for years, organisations have been ‘tracking and tracing’ their products with unique identifiers.
For healthcare institutions and pharmaceutical wholesalers, working ‘lean’ is becoming the new standard. For example, if your products do not have machine-readable barcodes, institutions might not purchase your products, as being able to scan all products, benefits them in many respects. Think of: having all relevant data available as soon as a product arrives, having insight of your stock levels, constantly knowing where it is or getting an alert when the expiration date is within e.g. a year. With traceable products, you are better prepared for your customers’ requirements and, of course, for your own efficiency improvements.
4 reasons to start today
As the legislation applies as of February 2019 (for medicines) and May 2020 (for medical devices1), you might think you still have time. But consider to start yet for the following reasons:
- Efficiency. Just because of the fact that efficiency is of increasing importance to you and your customers, traceability is recommended.
- Implementing traceability might require some significant organisational adjustments, think of:
- Redesign of packaging and labeling
- Adjustments to packaging lines and automation systems
- Documentation of adjusted packaging specifications and procedures including getting approval for them
- Validation of new or modified packaging processes, equipment, and IT systems.
- It is better to avoid rushing into (flawed) decisions. In case you need advice or support to design a new or modified process, the farther the deadline, the more time you have to consider your options.
- Practice in the United States has shown, that even with a segmented implementation and with a wealth of experience with UDI, manufacturers have difficulty meeting the deadlines.
The difference between Serialisation and UDI
The European Medical Device Regulation (MDR) 2017/745 published in 2017 elaborates on prior traceability regulations and introduces UDI for medical devices, which you should apply as of May 5th, 2020. UDI stands for ‘Unique Device Identification’ and consists of a device identifier (for manufacturer and model) and a product identifier (for packaging unit, batch, production date or expiration date). So, as it is prescribed now, ‘unique’ does not imply traceability of the smallest saleable unit.2
When reviewing Serialisation regulations for medicines, you will find that the identifier prescribed should be unique for every saleable unit, enabling traceability throughout the entire sequence from manufacturer to the last part of the supply chain, in particular cases even up to the individual patient. The Delegated Regulation (EU) 2016/161 published in 2016 introduces two safety features - a unique identifier (two-dimensional barcode) and an anti-tampering device - to be placed on the packaging of medicinal products as of February 9th, 2019. Although this level of identification for medicines is not yet required for medical devices, it is expected that future ‘Implementing Acts’ for the new MDR will include traceability of the smallest saleable unit, up to the patient as well.
So, what now? Start orientating and ask yourself questions like: What is your organisation’s situation at this moment? What is your knowledge of the legal requirements and of the efficiency opportunities? What should be your next step? What do you need for that? How much time will it take?
It’s well-advised to raise your knowledge level, provide a clear overview of your situation, do a gap analysis and provide solutions, explore different options, share best practices with others in the field, and start drafting an action plan. If you are uncertain about some aspects, don’t hesitate to contact us, we will be happy to talk to you about it.
Blog by: Louis Habets - Sr. Consultant & Trainer at Xendo
If the European Medical Device Database Eudamed not fully functional is on May 26 2020, numerous requirements listed in the MDR and relating to where any information needs to be stored in Eudamed, will apply six months from when the Commission has published a notice declaring that Eudamed has achieved full functionality. While waiting for Eudamed to become fully functional, the corresponding provision regarding the exchange of information in the MDD and AIMDD will continue to apply. This regards particularly Vigilance Reporting, Clinical Investigations, the Registration of Devices and Economic Operators, as well as Certificate Notifications.
When will UDI carriers really need to be placed on the label of devices and all higher levels of packaging as described in Article 123,3f, depends on the Risk Level of the product:
- May 26, 2021 for Implantable and Class III devices;
- May 26, 2023 for Class IIa and IIb devices;
- May 26, 2025 for Class I devices.
- How soon the UDI carrier need to be placed on re-usable devices is determined in Article 123,3g as:
- May 26, 2023 for re-use Implantable and Class III devices;
- May 26, 2025 for Class IIa and IIb re-usable devices;
- May 26, 2027 for Class I re-usable devices.