Medical device manufacturers have always faced complexity in the overall regulatory landscape of their industry. Complexity stemming from regulatory updates in an ever-evolving, quick-changing, global marketplace. Regulatory enforcement in the industry where the ultimate goal is always end-user safety.
The latest standard to shake the medical device industry is the EU Medical Device Regulation, or more simply known as MDR. The EU MDR regulatory standards improve upon previous directives while creating a similar standard to the FDA’s Unique Device Identifier (UDI) regulation within the European marketplace.
MDR updates a variety of classifications and definitions to create a more comprehensive product list, ultimately including the FULL portfolio of medical device options. All product categories termed “medical device” will now be regulated under the full, binding standard, including implementation of UDI track and trace (serial numbers, lot numbers and the like) programs.
MDR compliance was first published in 2017. The initial date was set for May 2020, but with the worldwide pandemic, Parliament voted to delay implementation to May 26, 2021, in an effort to avoid any further stress to the medical device supply chain. * We will continue to monitor as the new date of this year approaches. *
In just four months, we are fast approaching the updated compliance date when manufacturers are asked to apply these regulations to their medical device labeling processes. Full adoption, post sell-off period, is planned for May 2025.
As with any new regulation (think Proposition 65, etc.), there will be questions, clarifications and room for interpretation. You’ll remember our exploration of the changes resulting from Unique Device Identifier regulatory updates from the FDA (timelines, static/variable label identifiers, Global Unique Device Identification Database, etc.). In a similar way, we’d like to explore some of the specifics regarding this latest standard.
Each updated regulation asks global medical device manufacturers to review their protocols and update their labeling processes accordingly
…and MDR is no different in this case.
* This is by no means an exhaustive list of the implications of this newest standard, rather a high-level review of where labels, marking and variable print may come into play. *
Consumer Pressure for Transparency & Safety: Consumers in every market are demanding increased transparency in the global supply chain. Pair with this the governing bodies’ desire for improved safety and security for users and the growing trend in more robust traceability through a product lifecycle and we have resulting changes, improvements and enhancements to standardized regulation as a result.
At its core of improving user safety, MDR’s key standards require more information to be contained on the labels of medical devices along with improved traceability of these medical devices for life-cycle auditing rather than one-time product approval. Protection for the user comes in the form of more upfront harmonized databased information.
From a standardized medical device symbol MDR showing a package contains medical devices, to a number of symbols or instructions communicating specific regulated contents, the MDR is all about user safety. In the same way that we saw Proposition 65 require manufacturers to properly label outer boxes if the product inside contained a potential carcinogen. The MDR is requiring medical device manufacturers to warn users of specific contents.
Section 23.2 of the MDR Annex provides a listing of EU MDR labeling requirements for review.
Complications of an Ultra-Diverse Marketplace: Did you know there are 24 official languages in Europe? When MDR stipulates information must be multi-lingual in specific markets the device is sold, that is no simple task. MDR has recommended manufacturers utilize standardized symbols in place of multi-lingual warnings. Similar to symbology used in alternate industries (think GHS in the industrial market), harmonized symbols are easily recognizable and understood without language as a barrier. Not to mention, symbols take up less space on a label… and that’s valuable real estate! This standardization will also assist in avoiding inconsistencies in warning/instruction and markings across the region.
Business Impact of MDR (and future regulations!) The MDR calls for new information to be placed on medical device labels. This will result in upstream process changes calling for cross-department collaboration. New templates, new layouts, art revisions and approvals will all impact the final labeling processes. Not to mention the complication from increased information on already busy labels or small devices that don’t have the available space.
Collaboration across departments will be vital in implementing and maintaining the regulatory standards as outlined. Think, non-departmental, non-siloed, implementation teams to fully cross-check the MDR Annex against the manufacturing process and product lifecycle. Product Design Engineering, Packaging Engineering, Regulatory/Agency, Quality, IT, Brand Marketing and Purchasing may all be involved in an implementation effort.
Compliance is not just a safety concern, it’s a financial business concern. Strict enforcement of mandatory content could result in quarantined product, recalled devices and financial penalties for non-compliance… all negatively impacting the bottom line.
Bottom Line in regards to Label Processing: Ultimately, batch labeling and mass pre-printing of static device labels will need to shift to processing variably printed labels (either pre-printed and validated or print on demand) and matching each device to a specific (and traceable) label containing a specific code. Not only does this packaging process need to be revamped to include variable print, but record keeping of data also needs to follow suit. This is very similar to the shift in traceability we have witnessed in the automotive market. One by one, regulated supply chains are moving towards a track and trace mentality for supply chain transparency.
As we see regulation after regulation impact labeling it’s also important to “future-proof” your process improvements. What do we mean by that? Consider all the involved departments, processes and the like in the road to compliance. It’s equally important to ensure compliance for the current regulations as it is to set up a process that can quickly adjust / add / update to the inevitable update in future regulatory standards.
TLP is known for taking the lead when it comes to regulatory compliance and labeling. With over 30 years of experience, UDI and MDR compliance is just the latest in the transformation of supply chain compliance.
For a quick overview on how we’ve transformed variable print across a variety of industries, check out the short video here.
Interested in discussing directly with our engineering team? We’re here to be a partner in regulation compliance. Reach out to us now!