Medical device manufacturing companies are facing more regulatory changes on a global basis than perhaps ever before. Most companies that distribute medical devices in Europe still have a lot to do before the new European Medical Device Regulation (MDR) takes effect in 2020.
The regulations have far-reaching impact, and they are why labelling has recently become a mission-critical business system for medical device companies.
Given that potentially thousands of labels will be impacted, now would be a good time to take the opportunity to rationalize the global labelling estate.
“Rationalize Your Labelling Approach to Prepare for the EU MDRs”
By using the new regulations as an opportunity to cleanse their labelling data, device manufacturers can choose to make this the last time valuable resources are abstracted from day-to-day activities in order to hunt down the thousands of impacted labels.
The new EU MDR regulation puts labelling in a prominent position. It is critical for regulatory, labelling and operational professionals to gain a clear understanding of the impact of the new regulations on labelling.
For those not familiar with the acronym, an increasing number of regulatory bodies around the world, including the U.S. FDA and the European Commission, are requiring manufacturers to fulfill three primary requirements:
1) assign unique device identifiers (UDIs) to their products;
2) label those products with the UDIs in both human and machine (think bar code, RFID) readable formats; and
3) publish additional attributes about those products to regulatory databases.
UDIs consist of two numbers: A Device Identifier (DI) relating to the specific device model and its manufacturer, and an optional Production Identifier (PI) that provides such details as lot or batch number, serial number, manufacture date, expiration date, and any other important production-related data. All mandatory information must be included both as human-readable plain text and in a format suitable for Automatic Identification and Capture (ASIC).
There is no simple shortcut to this part of the process, but with the right approach, it becomes a downstream value-creating activity rather than a short-term business overhead.
And here is where Maven can help you.
Maven Profcon Services LLP is a Medical Device Consultant, provider of regulatory solutions for all size of industries not only India, but globally.
“It’s TIME to act NOW”
It’s important to remember, however, that no software solution is going to deliver a benefit without first carrying out the rationalization and consolidation activities discussed above. Organizations adopting this approach will find themselves better equipped to respond to future legislative changes, new market opportunities, and the inevitable day-to-day labeling challenges in bringing new products to market.
BENEFITS TO MANUFACTURER
- Stronger Customer Relationships
- Evidence to Tailor Marketing and Improve R&D
- Faster Regulatory Market Approval
- Earlier and More Robust Insight into Adverse Events
In the end, UDI compliance is a fact of life for manufacturers. They must either comply with the rule or risk no longer being able to sell their products in a given market. How a manufacturer approaches UDI compliance is less certain and can make the difference between more regulatory burden and higher costs of doing business or the opportunity to build better relationships with customers and building better products for patient care.
“Decide now what is better for your organization?”