The European Medical Devices Regulation in the Scope of Labelling...
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The European Medical Devices Regulation in the Scope of Labelling and Artwork

Karolina Komposh, Labelling & Artwork, Croma-Pharma

Karolina Komposh, Labelling & Artwork, Croma-Pharma

The new Medical Device Regulation (MDR) was adopted in 2017 and replaces the Medical Device Directive (MDD 93/42/EEC). These major changes and improvements were needed after a PIP scandal, where industrial silicone was used in implants and has put the health of the patients at risk.

Now, three years later after the publication of the European Medical Devices Regulation, the main stakeholders should be ready for the implementation of the strict requirements. The focus of the regulation is the safety of the patients that can be reached, inter alia, by accurate information provided by the manufacturer to the end user. This means that all instructions for use, labels, cartons and other documents accompanying the devices (like implant cards, standalone leaflets or inserts, etc.) should be revised and updated.

Mostly, this would mean a complete restructuring of the artwork in order to include all essential information or a change of your labelling equipment. Depending on the distribution regions, respective labelling translations should be prepared by verified translation agencies. As all the above-mentioned takes a significant amount of time (depending on the quantity of your products or product variants), most manufacturers at this point should have already prepared the print files for upcoming changes. The next major step would be obtaining the approval of the respective MDR accredited notified body, the number of which is at the present moment quite low.

"The next major step would be obtaining the approval of the respective MDR accredited notified body, the number of which is at the present moment quite low"

The international symbols that must be depicted in product labelling, have also partly changed and several of them are still under discussion between respective working groups and the European Commission. These symbols will have to undergo a validation process before they can be included in the harmonized standard.

Where applicable, the CE marking shall be followed by the identification number of the notified body responsible for the conformity assessment procedures. The identification number shall also be indicated in any promotional material mentioning that a device fulfils the requirements for CE marking.

It is now essential that the manufacturer specifically marks their device as a “medical device” by placing the “MD” symbol on their labelling. Detailed information regarding all new symbols can be found in the guidance issued by MedTech Europe.

The manufacturer should ensure that the labelling of the device includes a human and machine legible UDI number in order to allow better product traceability. The European database on medical devices (EUDAMED), which will be launched in 2022, will store these numbers and facilitate access to information on devices as well as reporting of safety corrective actions. The UDI can be placed on the product or label and other labelling layers. In case that there are space limitations, the UDI can be placed on the next packaging unit; or for single-use I-IIa class products, no UDI should be used on individual packs.

With only several aspects of the many to implement that were mentioned above and just five months ahead until the MDR becomes effective, there is still a lot work to do, and labelling experts are welcome to ask questions, exchange experience on their approach and correct the strategy when possible.

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