MDR is just months away. To prepare for the sweeping changes in regulation, medical device manufacturers around the world are streamlining their product portfolios and rushing to complete pre-clinical device safety testing. It’s a daunting process that runs the risk of products not meeting compliance and being pulled from the European market, but the good news is that there are steps you can take today to make sure you’re ready.
First, now is the time to rationalize your product portfolio. Start by mapping out each of your products and organizing them based on their age, how many generations are on the market, any quality issues that have arisen from them, and the costs that will be incurred with continued production.
The goal here is to streamline your portfolio as much as possible. You might have some products that can be retired because you’re producing newer versions of them. Or, if a product has had past performance problems or is not satisfying your desired ROI, now is the time to decide whether it’s worth continuing to market and sell it in Europe. For products you’re pulling off the market, we recommend consulting with your quality, regulatory and legal teams to make sure you’re removing the product effectively and with low risk.
For the products that have made it through your rationalization process, there are two paths to take: prepare to register them under MDR, or plan to develop their next generation according to MDR guidelines.
To get your device ready for registration, you’ll need to compile data and run tests on its compositional elements. In doing so, you’ll improve the likelihood that your product successfully passes MDR certification. The first step is for your internal team to compile existing data on the materials that make up the device, including adhesives, additives, colorants, polymers, manufacturing aids and more. The procedures used in the manufacturing and sterilization processes should also be reported. This data will help you evaluate what tests will be necessary to comply with the new regulation.
It’s important to note there are three phases of testing involved in a complete biological evaluation under ISO 10993-1 and MDR: chemical characterization, toxicological risk assessment and biocompatibility testing.
Chemical characterization, also known as an extractables study, involves exposing the device to aggressive solvents to identify and quantify chemical constituents contained within the device. Toxicological risk assessments, which use the information found in chemistry reports, establish a margin of safety for each chemical and determine what additional tests are needed to further mitigate any safety concerns. Biocompatibility testing looks at how living cells react to the device. (Note: if chemical characterization meets some biocompatibility endpoints, it may not be necessary to do biocompatibility testing.) Together, these evaluations generate data on the physical and chemical makeup of the device in order to demonstrate its safety and achieve MDR compliance.
Partnering with a lab or contract research organization (CRO) can help you can stay on top of your timelines before MDR goes into effect, as their expertise can serve as a valuable resource in efficiently adhering to the new requirements. Once you’ve begun to work with an outside organization, communication is key: provide a forecast, inform them of what samples they can expect and when, and make sure they have testing capacity. You should also provide them with thorough technical information so they can set appropriate testing parameters. Finally, prepare and provide a test article that is truly representative of the manufactured device to ensure accurate results.
Meanwhile, developing the next generation of your device under MDR guidelines is also an option. This might be valuable to consider if the device has created patient safety issues, is falling behind your competitors’ products, or if it utilizes a hazardous sterilization method – such as ethylene oxide (EO) – that could be substituted with another method instead.
Here too, the data provided to you by a lab can help guide you through the development of the next iteration of products that will meet MDR guidelines. It’s up to you to determine which course of action will be the most effective for your organization.
Getting organized now will help make sure you’re ready for MDR in May. Create a strategy that starts with rationalizing your product portfolio. For the products you’ve identified for continued sale in Europe, consider partnering with an experienced lab to expedite the testing process. You may be hoping Europe will delay MDR implementation, but you shouldn’t count on it. If your company is behind, it’s time step on the gas. For more tips on how to get started, check out “Preparing for MDR: How to conduct a gap analysis.”
WuXi Medical Device Testing offers testing services in St. Paul, Minn., Atlanta, Ga., and Suzhou, China.
