Navigating Converting Your Product Lines to Sterile Packaging

In spring 2017, the European Parliament approved and formally adopted the EU Medical Device Regulation (MDR). In brief, the MDR is a regulatory push to increase medical device safety in the EU market. It specifies that devices delivered in a sterile state should be designed, manufactured, and packaged with appropriate quality-controlled procedures, ensuring sterility when they are placed on the market. Many OEMs have been planning to convert their non-sterile product lines to sterile packaging in the time since the MDR was formally adopted.

Although packaging is still considered an accessory to a medical device, the MDR specifically addresses packaging and labeling. As a result, changes to packaging and labeling need to be considered in your overall compliance timeline. The MDR is set to be fully enforceable by the end of May 2020, which is just six months away. At this point, many OEMs are feeling the pressure with the date of enforceability looming.

The reason is that anytime a change is introduced into established processes and procedures, risk increases. Risk can include voluntary and mandatory recalls, threats to patient safety, unanticipated costs, and the ramifications of such events on an OEM’s reputation. Let’s take a closer look at just a few.

Voluntary and mandatory recalls

In the orthopedic device industry, the majority of recalls are the result of improper packaging or labeling. While often not a direct threat to patient safety, such recalls can be complex to manage efficiently and effectively. Product in the field needs to be brought back within the OEM’s control and packaged or relabeled, depending on the nature and extent of the error.

With the required changes in labeling under the EU MDR, the need for correct labeling data under new procedures needs to be carefully considered. For example, once MDR is fully enforceable, products need to be labeled “sterile” in a box label as well as bear CE marks under Regulation 2017/745. There is no provision for grandfathering CE marks under previous directives.

Recall processing costs

While an investment is certainly required to change established processes and procedures to ensure compliance, the cost of processing a recall can be much, much higher. Consider the labor and resources required to bring mislabeled product back under your control from a multitude of geographical locations. Consider also the need to correct the packaging or labeling and get the product quickly back out into the field in a timely manner.

Velocity and the bottom line

For many global OEMs, ensuring MDR compliance is key to maintaining sales volume and velocity. As product lines are converted and new products are brought to market, careful revision to established processes reduces the risk of not only a recall but also a slowdown or halt to production that could drive up backorders and frustrate existing demand.

If you’re feeling the pressure to successfully convert in advance of full enforceability, we can help. At Millstone, we’ve created a quality system that matches those of our manufacturer clients. Every day, we process thousands of pieces in our 276,000-square-foot facility. In addition, we have the industry perspective and expertise to help your team negotiate the critical changes required to ensure compliance with new regulation such as the EU MDR.

At Millstone, we get it. We believe quality drives patient success. That’s why we’ve perfected all the capabilities medical device manufacturers need to get to market. Today we offer post-manufacturing and aftermarket services to more than 50 customers, including some of the top 10 orthopedic companies in the world. We are constantly evolving our processes and services to help OEMs achieve sustainable success. We offer clean room packaging, medical device specific warehousing, finished goods distribution, loaner kit management, advanced inspection and reverse logistics services—all with an unparalleled focus on quality.

What could we help you do better? Learn more at


Comments are closed.