Class Ir Device Manufacturers Must Keep Their Feet on the Gas

The recent deadline extension for Class I reusable devices (Class Ir) to comply under the Medical Device Regulation (MDR) can be a relief for all impacted parties. However, while an extension alleviates some of the pressure for the time being, medical device manufacturers should take advantage of the additional time to effectively prepare. With the new deadline for Class Ir devices set for May 26, 2024, manufacturers must keep their foot on the gas. If the MDR process to date has been any indication, these next four years will go by fast.

Why This Is Happening
The transition to the MDR has been a sizable feat for the medical device industry, leading to bottlenecks in the submission process from both notified bodies (NBs) and testing labs due to the influx of devices to be reviewed and the depth of review required. This extension relieves some of that pressure. Ensuring there are sufficient medical supplies available in the EU is a top priority for regulatory officials, so delaying the lower-risk Class Ir requirement allows greater focus on higher-risk devices. Officials have long asserted the MDR implementation deadline would remain intact, to the objection of many within the industry. Allowing more time for lower-risk devices is a compromise that alleviates pressure on all devices and prioritizes regulatory reviews in a risk-based order.

Beyond alleviating the immediate product load for NBs and testing labs, there are other benefits to the Class Ir extension (intentional or not). For manufacturers, this could mean bringing new life to products that were slated for end-of-life under the original deadline. Still, with the unpredictability and delays already faced in NB availability and capacity, promptly compiling technical files is as important as ever.

Maintaining a Spot in Line
Both the availability and capacity of NBs are behind predictions for this point in the MDR implementation process. Even with the Class Ir extension, there are no promises this situation will improve, so manufacturers should factor this element into their planned validation processes. The extension allows NBs to meet a more manageable pace of commercializing devices under MDR, but with uncertainty around how exactly this affects their capacity and prioritization of devices, manufacturers need to be ready with their validations and technical file documentation at a moment’s notice to respond to their NBs’ availability.

Without a guarantee of when the review window will open, manufacturers not ready to go when their NB is ready for them may be at a disadvantage. Conversely, manufacturers who are prepared well in advance are more likely to reduce the risk of their device’s submission missing the deadline—even with the extension. While the number of NBs is expected to increase, there is no assurance on the future, so it’s important to plan for the worst-case scenario.

Getting Files Together
In the past, validation standards were not enforced uniformly for Class Ir devices, so manufacturers had a lot of autonomy to self-designate the interpretation and execution of testing. But to obtain a CE mark under the MDR, even these lower-risk devices must include a detailed technical file proving the safety and efficacy of cleaning, disinfection, and sterilization methods are adequate and validated in the device’s Instructions for Use (IFU). An NB will review these technical files, including the validation of the IFU, following current industry norms, regulatory standards, and experimental design principles to confirm they comply with the MDR and are acceptable according to international standards and regulatory expectations.

With this change, manufacturers face a significant demand to provide documentation, which will likely require increased testing and lead to a longer preparation timeline. Manufacturers may also need to involve more partners in this process to achieve the best possible outcome. For all, this submission process now includes an NB, and for most, it also includes a laboratory testing partner to acquire new or supplemental data.

Preparing technical files for Class Ir devices under the MDR presents additional challenges outside of the unpredictable regulatory timelines. MDR compliance requires confirming that validations exist to support IFU claims in the design file for all devices in their product portfolio and that validations meet current standards and guiding principles. Both requirements are time-consuming components of the newly mandatory documentation. Also, while testing labs’ increased exposure to like devices and the regulatory climate makes them an asset to any team, some labs will still face constraints and potential delays. Identifying one of the many testing labs that have drastically increased capacity in response to MDR needs can be a beneficial step in this process.

To make the most out of a partnership with a testing lab, manufacturers should come to the table with clarity around their needs and current information gaps. Start the process by reviewing technical files for Class Ir devices to identify where further information is needed. If a product family consists of multiple products and SKUs, validation evidence that covers all the devices will need to be documented.

If validation testing is required, the manufacturer should start by identifying the type of study or studies needed for each product and product family. Some examples of the studies that may be needed include cleaning, sterilization, dry time, disinfection validations, or durability testing for support for functionality.

Because these studies can be costly and time-consuming, it is essential they are performed correctly the first time. Manufacturers would be wise to use the extension to reevaluate what to include in their testing scope and work within new windows to gain approval.

A Broader Extension?
Given the adjustment to the deadline for Class Ir devices, many are wondering what this extension implies for the greater MDR. Could it mean an extension for the entire regulation is imminent? The answer—currently—is no.

While many may be hoping there will be additional extensions in the future, officials continue to maintain this is not likely, and holding out hope for one could put products and companies at risk, especially this close to the May deadline. Extending the deadline for this subset of devices was intended to relieve some pressure on the industry—enough to let NBs focus first on higher-risk devices. A smaller extension for just Class Ir devices makes more sense than a full extension because it allows manufacturers and NBs to prioritize devices that have the potential to pose a greater risk to patients. In addition, it allows more time for the class of devices not previously required to provide documentation to the degree required by MDR. Overall, the goal is this limited extension is enough to avoid the need for additional extensions.

Doing More With the Extra Time
Manufacturers may be asking themselves how these considerations impact their preparation plans, and if it’s not clear yet: keep an urgent pace. Industry veterans know how quickly time can pass when approaching a new requirement deadline, and the last thing manufacturers want is to end up in the same stressful, and potentially costly, situation they faced before the extension.

While pressure on NBs and testing labs has temporarily been relieved, there’s still no guarantee of what the coming years will bring. It’s in each manufacturer’s best interest to plan for the worst-case scenario because without control over their working timelines with partners, their devices could fail to maintain or earn their place in the market. Manufacturers should work as fast as possible and let any delays in this process be the result of partner prioritization and capacity constraints, rather than their own failure to plan ahead.

Instead of delaying product file preparation, manufacturers can take full advantage of the extension by keeping pace with their priority products as well as focusing on products they previously considered discontinuing. This opportunity is ideal for reevaluating whether to retain these devices in the market under the MDR. Reassessing products not currently included in their MDR portfolio could deliver a higher return on investment than simply slowing the validation process of the products currently in the validation queue.

Putting the Pedal to the Metal
While the Class Ir extension may not give manufacturers the time to sit back and relax they may have hoped for, the future of Class Ir devices is still full of opportunity. Identifying gaps in devices’ technical files, bringing in the right testing partner to guide new documentation, and giving life back to devices that may have been on their last leg can all support companies’ bottom lines and broader business goals.

Manufacturers shouldn’t let up on Class Ir preparations under the MDR and should remember to establish relationships early to avoid capacity constraints. 

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Dan Fowler is a principal scientist with WuXi Medical Device Testing, located in Atlanta, Ga. He has more than 20 years of experience in medical device third-party reprocessing. His expertise includes a concentrated focus on interpretation and application of AAMI TIR30. Fowler executes identification and validation of analytical laboratory assays and develops best practices in method development for inoculation/extractions and efficient cleaning/disinfection strategies. WuXi Medical Device Testing offers testing services in St. Paul, Minn.; Atlanta, Ga.; and Suzhou, China.