In the past, there was very little need for medical device identification. With the adoption of the upcoming EU Medical Device Regulation (MDR) this will all change. We spoke with Volker Watzke, Domino’s EU Medical Devices Sector Development Manager to get his insight.
Changes in the medical devices sector
We started by asking Volker to explain the biggest changes in the EU medical device market with regards to coding and marking. He started by saying that in the past manufacturers would put article numbers on their medical devices but there was no clear traceability of these products. From now on all medical devices sold in the European market will need to have a Unique Device Identifier (UDI-DI) and this code would need to be registered in the EUDAMED (European Database for Medical Devices).
Volker emphasised that the deadline for this to be completed by is May 26th, 2020. Domino’s research has shown it typically takes 12 to 18 months for manufacturers to become UDI compliant and so manufacturers should have already started to plan. After the initial deadline the roll out of UDI coding onto each medical device type is tiered, depending on the medical device’s product classification.
Volker described the three classes of medical devices. Class III, the critical risk medical devices, includes life-sustaining and lifesaving products such as pacemakers. Class III medical devices will be the first to require a UDI code on the product and on the associated packaging. The deadline for this being May 2021. Then the roll out of UDI coding onto Class IIa/b and Class I medical devices will be from May 2023 and May 2025. A similar roll out is planned for labelling In-Vitro Diagnostics (IVD), Class A, B, C & D IVD labelling starts from May 2023 and ends May 2027.
Currently there is very little coding equipment on medical device production lines for printing variable data onto products. It is not only the coding equipment that needs to be updated and integrated but also the vision system that enables the upload of data to the EUDAMED
The importance of UDI
Volker described how UDI is important at every stage of the supply chain. If hospitals use a machine or human-readable code on every medical device they can keep track of quantity levels for each product and also ensure that the correct product is being prepared for surgery. By having the ability to scan each medical device they will be able to reduce the number of medical errors and increase patient safety.
We asked Volker how this used to work. He explained that in the past numerous medical devices only had an article number assigned by the manufacturer. If there was a need to recall more than one product or a specific batch of products this would have been difficult to do. Now with the introduction of UDI this will make the recall process easier. More importantly, the requirement for medical device products to be registered in EUDAMED ensures only products that have been registered in EUDAMED can be sold in the European market. This will result in a positive evolution of device identification for each part of the supply chain.
Firstly, manufacturers need to review all their products and identify which product is related to which class. Are they critical risk, high risk, medium risk, or low risk? The application for the UDI number for all medical devices needs to be done by May 26, 2020. The actual marking on the lowest packaging level needs to be related to the classification, 2021 for Class III, 2023 for Class II products, and 2025 for Class I products.
What are the relevant UDI coding technologies?
Volker mentioned that due to the wide range of medical device products available on the market, there are various coding and marking technologies that are suitable and meet the requirements set out by the EU MDR. When it comes to preprinted labels on the primary packaging level, Thermal Transfer Overprint (TTO) or Thermal Ink Jet (TIJ) are the best coding solutions. If Direct Part Marking is required on higher risk and reusable medical devices, laser would be the most appropriate technology to use.
For smaller medical device manufacturers, Print and Apply (PALM) labelling technology enables the manufacturer to print labels in advance of applying the label to the product. For many medical device products, the label can be foil, aluminum, plastic or paper labels.
Domino provides validations packages to help manufacturers validate their products and prepare for the upcoming EU MDR. Domino’s range of coding and marking solutions offer manufacturers of medical devices the most suitable technology in order to achieve UDI compliance.
To discover more on medical device coding and marking requirements under the new EU MDR, download our white paper!