The E.U.’s new medtech regulations are scheduled to go into effect in 2020, giving manufacturers who want to continue selling their devices in Europe lots of work to do.
With the E.U.’s Medical Device Regulation (MDR) coming into effect in less than a year, medical device manufacturers are scrambling to prioritize their product lines and work through testing. Many manufacturers are hoping the E.U. will delay implementation, but don’t count on it. If your company is behind, there’s still time to catch up, but it’s imperative to get organized now.
The first step, if you haven’t started planning for MDR, is to rationalize your product portfolio. One common challenge in the rationalization process is a lack of clinical experience reports, particularly for older products. The need to unearth relevant documents presents a time-consuming obstacle requiring your team to either dive into literature or actively seek client input to satisfy reporting requirements. This extra work is one reason legacy products should be prioritized in the rationalization process.
Get organized
Every company’s approach to rationalization will differ, but here are a few questions that every manufacturer should ask themselves during the process:
- Do your products have multiple generations on the market? If your answer is “yes,” prioritize your options with return on investment (ROI) in mind.
- Will the cost incurred to keep this product on the market satisfy your desired ROI? If your answer is “no,” it may be time to stop selling the product in Europe. Conducting a cost-benefit analysis will be important to align with business objectives.
- Can you group any devices into product families for evaluation? Group devices together and test a smaller sample to cover the worst-case scenarios of a broad category. This will help increase efficiency.
- Have you rectified any quality issues in your devices? Take the time to review your quality checks and any clinical feedback that has surfaced. Any evidence of past performance problems that have put patients at risk will be an automatic issue for regulators if you are unable to show that the issues have been resolved.
Understand your options
Once you’ve rationalized your product portfolio, you have three options for what to do with each device. First is the option of moving forward with registering the device under MDR. Second is the option to end the life of the device in Europe. Third is to develop the next generation under MDR and extend the current product life under the Medical Device Directive (MDD). With each option comes unique considerations.
Register your device under MDR
For products that have a healthy ROI and wouldn’t benefit from an upgrade or redesign, registering the device under MDR is likely the best path forward. To start, your internal team should compile existing data on the materials that make up the device, including adhesives, additives, colorants, polymers, manufacturing aids and more. Procedures used in the manufacturing and sterilization processes should also be reported. This data will help you and your lab evaluate which tests are necessary to verify safety.
There are three phases involved in a complete biological evaluation under ISO 10993-1 and MDR: chemical characterization, toxicological risk assessment and biocompatibility testing. Chemical characterization involves exposing the device to aggressive solvents that identify and quantify chemical constituents contained within the device; this is called an extractables study. Extractables studies are followed by toxicological risk assessments, which use the information found in chemistry reports to establish a margin of safety for each chemical and determine which additional tests are needed to further mitigate any safety concerns. The last stage is biocompatibility testing, which looks at how living cells react to the device.
Chemical characterization studies might meet some biocompatibility endpoints, which may eliminate the need to do biocompatibility tests. Using your chemistry data and risk assessment to drive your biocompatibility test plan can also help you avoid unnecessary animal testing and reduce the number of devices needed for testing. Together, these evaluations generate data on the physical and chemical makeup of the device to support and prove its safety and achieve MDR compliance.
End the life of the device in Europe
Reasons to consider ending a device’s lifecycle in Europe include ROI considerations, quality issues or obsolescence due to the existence of next-generation devices. Be aware that there may be liability risks that arise as a result of devices remaining in-market in Europe, even after they’re no longer sold there. Consulting your quality, regulatory and legal teams is essential to pulling out of market effectively and with low risk.
Develop the next generation under MDR
Developing the next generation of a device under MDR and extending the current product’s life under the MDD is fitting when you are addressing quality issues, enhancing features and/or considering alternative sterilization methods. Consider this option if the device has created patient safety issues, is falling behind competitors’ products, or if it employs an ethylene oxide (EO) sterilization method but could undergo an alternative method. EO is hazardous to the environment, expensive and has proven to be unreliably available. Other sterilization methods, such as radiation, can be more cost-effective and environmentally friendly.
Partner with a lab
Working with a contract research organization (CRO) to complete your testing needs can help your organization maintain efficiency and catch up with the competition. Communication is key. Provide a forecast to your CRO and tell them which samples they can expect and when; this will allow the lab to reserve testing space and adjust capacity, if possible, to better meet your needs.
Next, you must provide thorough technical information, so the lab is able to set appropriate testing parameters and have access to the right equipment and solvents. Be prepared for CROs to ask highly detailed questions about specifications like device surface area, patient contact time and whether the device can be cut into sections.
Finally, provide a device for testing that is truly representative of the devices produced by manufacturing. Using a prototype, for example, could yield inaccurate results and put your submission’s approval at risk because prototypes may be made of different materials or employ a different manufacturing process.
Getting organized, understanding your options and working collaboratively with a CRO can put you on the right path toward MDR compliance, even if you’re getting a late start. Don’t sit idle and hope MDR will be delayed. For more tips on how to prepare for MDR, read “Pre-clinical medical device testing under ISO 10993-1 and the MDR” and “What you need to know about reusable devices and Europe’s MDR.”
