Lately, there’s been quite the buzz around the European Union Medical Device Regulation or better known as, EU MDR. The EU MDR is a priority for all companies in the medical device industry that distribute products in the EU and will officially take effect on May 26, 2021. This regulation has more need for data management and complex assessment procedures than the regulation it replaces (MDD – Medical Devices Directive). All other classes of devices can continue to be sold under a valid MDD certificate until May 2024 or the MDD certificate’s expiry date. As the deadline approaches, there are some key labeling elements that medical device companies must adhere to for EU MDR compliance. Within this blog post, we will break down what EU MDR is and how it will impact your labeling process.
1. What is EU MDR?
The EU MDR is designed to ensure public health and patient safety across Europe and to increase quality and transparency of medical devices in the healthcare supply chain through label design, label approval, and label tracking standardization. Many organizations within the healthcare industry who have medical devices that are implantable, life-supporting, or life-sustaining must also bear a Unique Device Identifier (UDI) on its labels, which includes:
Device Identifier (DI) which is a unique numeric or alphanumeric value associated with a specific version and model of a medical device.
Production Identifiers (PI) which includes information such as a lot number, serial number, manufacture date, and expiration date. If they are on the label in easily readable plain-text, they must also be in the Automatic Identification and Data Capture (AIDC) format.
Human Readable Information (HRI) which is a representation of data that can be naturally read by humans.
UDI issuing agencies for EU MDR are:
Healthy Industry Business Communications Council (HIBCC)
International Council for Commonality in Blood Banking Automation (ICCBBA)
Informationsstelle für Arzneispezialitäten (IFA) GmbH
2. When do I have to comply with EU MDR?
All medical device manufacturers doing business in Europe must comply with EU MDR guidelines by May 26, 2021. This regulation applies to all organizations doing business in Europe, meaning medical devices manufactured outside of the EU, but distributed throughout European Union nations will also need to comply. The final compliance deadline for all classes of medical devices manufactured is May 26th, 2024.
3. What are the EU MDR labeling guidelines?
Unique Device Identification (UDI) component in EU MDR labeling
The medical device manufacturer needs to correctly submit the UDI information to EUDAMED (European Database on Medical Devices) and maintain all UDIs for its devices
The UDI needs to be on the label of the device or on its packaging, or in the case of reusable devices, on the device itself (direct marking)
Want to learn more about UDI compliance? Listen to our webinar recording here
Inclusion of lot and serial numbers
Active devices will have independent, unique serial numbers while implantable devices will require lot or serial number. Which means, the EU market will shift from batch labeling to every product having its own unique serial number.
Written text is now required on the label to be compliant with EU MDR when announcing a warning or precaution for the labeled product.
Must indicate CMR (Cardiovascular Magnetic Resonance Imaging) The new EU MDR guidelines recommend manufacturers announce the presence of CMR substances, if accurate, on the label.
Medical device symbol is required Manufacturers must place the medical device symbol on their label stating that what they have packaged is in fact a medical device.
Universal symbols ca be used for ease of global use
There are 24 official languages in Europe, which creates a necessity to translate the information provided on the labels into multiple languages, depending on where the device is made available. This requirement can be dealt with by using symbols. The use of symbols on the label as an alternative to written language is permitted in the EU MDR noting that symbols are efficient, cost saving and internationally understood concepts to convey the required information to the user of a medical device.
Some examples are below:
Contains human blood or plasma derivatives – any medical device that incorporates cells, tissue, or other medical substances must indicate this on their label.
Contains biological material of animal origin:
Contains a medicinal substance:
4. How can TEKLYNX help?
Whenever a new regulation is introduced, it can be stressful and overwhelming to iron out the new guidelines that you must comply with. With new designs, icons, and even sizes of the labels, it can be difficult to find EU MDR labeling software for your company.
The cost of not having EU MDR labeling software implemented for your company can cause even greater stressors for your company though by facing quarantined products, recalls, and even financial penalties or other sanctions due to non–compliant labels. Luckily for you, TEKLYNX has two EU MDR labeling software solutions that will help you easily and seamlessly comply with this regulation.
CODESOFT is an advanced barcode label creation and integration software that gives you the ability to easily design and print your EU MDR compliant labels. This EU MDR labeling software includes easy-to-use GS1 and HIBCC barcode wizards built directly into the software to help streamline the barcode creation of those barcode symbologies.
Below is an example of an EU MDR compliant label that was created in TEKLYNX EU MDR labeling software, CODESOFT.
TEKLYNX CENTRAL CFR
Companies importing or distributing devices in many countries need to evaluate their labeling system and consider centralized label management, which enables better label management across locations and countries with varying requirements and languages.
If you have a multitude of compliant labels to create, the need for a single, unified solution to handle label design, approval, printing, and reporting may arise. TEKLYNX CENTRAL CFR seamlessly pulls label elements from a centralized database, giving you the ability to design and print EU MDR compliant labels 100% of the time. You also can apply role-based labeling access to your labels to ensure security, accuracy, and peace of mind knowing there won’t be labeling errors which can cause recalls. With TEKLYNX CENTRAL CFR automating your entire labeling process is efficient and seamless by ensuring process enforcement and additional control with a web interface hosted by your company.
Below is a quick video to see what else TEKLYNX CENTRAL CFR can do for your company.
Don’t wait to start using EU MDR labeling software!