MEDdesign

EU MDR, UDI and Master Data: How to Ensure Label Compliance

By Josh Roffman
June 24, 2019


• Categories: 03-Manufacturing Execution, 05-Quality/Regulatory, Combination Products, MEDdesign, RC - Medical Device Labeling

The 2017 European Union Medical Device Regulation (MDR) deadline of May 26, 2020 is fast approaching. Beyond UDI, the EU MDR has additional regulatory requirements, and the device compliance categories have also broadened. In the wake of this rule’s passage, it is essential that your company have immediate access to the technical documentation on the products you are manufacturing or selling. This process is especially complex if you are in the OBL (own brand labeling) field instead of producing equipment in-house, and in all cases, it demands effective master data management. Upgrading your enterprise labeling system may be a key element of getting and staying in compliance.

The Impact of the 2017 EU MDR Rules

Now is the time for medical device providers to get their products in compliance with the 2017 EU MDR changes, ahead of the effective date of May 26, 2020. This process will involve determining which policies and technologies within your organization must evolve to fully comply with updated rulings.

It seems that delivery of relevant data by manufacturers is more stringently regulated under the new version of the rules. Companies will now have to be diligent and quick about reporting injuries, deaths or other incidents involving medical devices. The information goes into a purpose-built online portal and will create a database for patients to access. The deadline for reporting incidents that did not lead to death or a major condition deterioration is shortening from 30 days to 15 days. UDI is one of the ways to track information in this database and will be stringently enforced.

Even if your company didn’t previously fall under the MDR regulation, 2020 may still be a significant compliance deadline. Some devices which weren’t covered under previous versions of the European regulations are now included. This makes it essential to check your entire product line against the categories of equipment that need to be registered and tracked.

Technical Documentation Needed

The informational portal EUMDR.com noted that staying in compliance with the latest regulations is a years-long process, rather than a one-off event. As a medical device manufacturer or seller, you have to produce technical specifications on individual pieces of equipment 10 to 15 years after they are put on the market for the final time. This means that even if a device goes out of production, you may still incur penalties for not carrying related documentation more than a decade in the future.

Not only must original technical documentation be available on demand, it also has to be up to date. EUMDR.com added that any updates or changes made to technical specifications during a device’s time on the market have to be accessible alongside the original specs for a device variant.

The data management and access needs related to these demanding new rules are stringent and wide-ranging. You need to be able to trace any equipment you receive or provide to an importer or distributor or sell directly to medical providers. Whatever your company’s place in the supply chain, from assembling devices from raw materials to re-labeling completed hardware or anything in between, you’ll be called on to have instant access to comprehensive records.

Improving Data Management and Labeling

While there’s never a wrong time to update your organization’s approach to data access, the implementation of new compliance standards is the ideal moment for such a move. The first step in making such a change is to study your current data entry and storage systems. Do you have multiple repositories for data? Is there a great deal of manual copying and inputting of content? Are some of your databases offline, consumer-grade systems instead of industry-focused software? If so, it’s time to start fresh with a single, central repository for data and integrated systems that allow that one database to become the source of truth for related operations such as enterprise labeling.

Integration and connectivity are the essential elements of a refreshed data management system. Giving all relevant departments and partner organizations access to relevant information in a centralized form takes away the risks of unnecessary duplication and the potential errors that come along with it. Using a modern labeling solution that draws directly from that main data repository enables your organization to ensure the devices you are shipping are accurately accounted for in your databases, a must for MDR compliance.

Labeling directly integrated with centralized data repositories is a valuable compliance tool, especially in times of regulatory change. When authorities demand new and more informative label designs, officials can make changes once and know they will be reflected on all relevant labels. A violation of regulations can set your company back with fines and penalties, making it worthwhile to always stay one step ahead of new rulings.

Ultimately, when it comes to managing medical device labeling, you’ll want a solution that enables compliance with UDI, EU MDR and 21 CFR Part 11 regulations and supports validated environments. To ensure compliance, it’s critical that your solution provide audit tracking and security controls combined with workflow management and eSignature capabilities.