We show you how to efficiently implement the EU MDR and UDI requirements. Increasing regulatory requirements and the digitalization of processes are the focus here.
Impact of the EU MDR on existing labeling
With the Medical Device Regulation 2017/745 (MDR), which came into force on May, 26, 2021, existing labeling systems and processes are once again under scrutiny. Companies that have not yet established a generic approach to labeling must adapt their labeling for each product and packaging stage.
How easy is it to implement the new regulatory requirements of the EU MDR with the existing system?
Depending on the respective product portfolio and the release workflow, this can mean considerable outlay for a company. The requirements regarding the UDI (Unique Device Identification), which must be stored in the European database EUDAMED, also indicates that singular, static and non-networked labeling systems will soon be obsolete. It would therefore appear to make sense for many companies not to invest the time and effort to implement the MDR in an old system, but instead to do this for a new, flexible and efficient system.
Labeling system requirements
With end-to-end digitalization of the labeling process and deep integration into SAP’s existing data architecture, you achieve a «Single Point of Management» and a «Single Point of Truth» for your labeling.
This reduction in complexity makes it much easier to perform a CSV (Computer-System-Validation) and enables our customers to offer numerous stable and reliable functions that are required for labeling in highly regulated industries:
Experience medical product labeling live?
Do you want to know how a generic labeling method can help you to implement the European Medical Devices Regulation (EU MDR)? Or are you interested in how it is possible to print only verified data via the UDI?
The top 6 challenges in labeling
Based on the experiences of our customers as well as the labeling system requirements for implementing the Medical Devices Regulation, we have put together the 6 most important challenges for labeling in the MedTech industry for you.
Generic design
A generic approach to product labeling can save the most resources. We know all the tricks when it comes to implementing such an approach, but also where the limits are. With the label designers that we offer, you have professional tools for handling this work.
Symbols & Logos
Symbols for approvals, compliance with specific requirements or other regulatory requirements must also be printed on the label in the correct size. Depending on the product and the country of destination, other symbols may be necessary. Control of these symbols as well as their correct rendering requires special attention.
UDI – Unique Device Identification
Printing barcodes or 2D codes for UDI is a key requirement of the EU MDR. Special attention must be therefore be paid to this point. Labeling systems must be able to print 1D and 2D codes while meeting standards such as GS1.
Multilingual labels
The languages you print in for labeling depend primarily on the destination country of the recipient of your products as well as local regulations. With the conditions you define in label management, the languages can be controlled based on the destination country or recipient. The template enables you to use dynamic arrangement of languages to print multiple languages with minimal space requirements.
National & International Regulations
As with language discovery, you can also consider other regulatory requirements for each target country with our rules. With a sensible structure for the regulation conditions, you always know what has to be printed in which country. What’s more, this gives you the opportunity to make specific customer requirements easy to maintain for the specialist department.
Data validation & Label approval / release
An ERP system like SAP is very hungry for data. All of the data from ordering, procurement, production to delivery is recorded automatically, but some of it is also recorded manually. Hardly any company can rule out errors in this flood of data. With such labeling, an incorrect data record can have serious consequences. That is why we developed the Content & Alert Manager, which provides companies in sensitive industries with an additional tool for validating data as well as approving and releasing labels.
What things need to be considered in the EU MDR?
In our white paper on the Medical Device Regulation, we explain all the influencing factors that must be taken into account in labeling. A checklist and recommendations on specific requirements will help you to quickly find your way around the EU MDR.
Exciting products for medical device manufacturers
Customers from the medical device industry
How do you coordinate changes to the CCDS with production?
Book a personal consultation appointment with our labeling experts to obtain some advice. We show you how easy it is to implement the EU MDR with our system and use data from the CCDS, such as the UDI, for your labeling.
Consultation on EU MDR labeling
