Despite the Class Ir MDR deadline extension, manufacturers must keep pace with compliance efforts to prepare for more potential, unpredictable turns.
As preparations for the EU Medical Device Regulation (MDR) continue, many manufacturers are relieved to have been granted a four-year deadline extension for Class I reusable devices (Class Ir), giving them until May 26, 2024 to comply. While the extra breathing room is beneficial for Notified Bodies (NBs), manufacturers and testing labs alike, it is important to remain proactive and make the most of this additional time.
Many Class Ir manufacturers were facing close calls under the original 2020 MDR deadline – which has also been delayed one year until 2021 – and tight timelines could reemerge, if the reality of capacity constraints and timing is not top of mind. As you approach Class Ir device MDR preparation, be sure to consider potential challenges that won’t necessarily resolve with extra time.
Beware of bottlenecks
While bottlenecks can occur at any point in the validation process, NBs arguably needed the relief of this extension more than anyone. Many have faced long delays in obtaining approval to operate under the MDR, and several are still waiting. Further, several NBs previously running under the MDD decided not to pursue MDR designation, which exacerbates capacity constraints for remaining NBs. As pressure builds, delaying lower-risk Class Ir devices provided one opportunity to relieve regulators.
As NBs continue down unpredictable timelines, you must keep a foot on the gas. It is unclear where exactly Class Ir devices fit into regulator priorities with this extension, so you should be prepared at a moment’s notice to provide your data to a NB. Treat your preparation timeline as if nothing has changed. You can also use this given time to reevaluate devices you may have previously shelved, as this could be the perfect opportunity to bring those under the MDR.
Sweeping changes
Preparing Class Ir devices for submission under the MDR has become a much more extensive process for most manufacturers. Historically, Class Ir devices were self-designated, meaning manufacturers decided what validation entailed. Moving forward, this will no longer be true. To obtain a CE mark under the MDR, you must provide a detailed technical file that attests to your device’s safety, efficacy of cleaning, disinfection and the required sterilization methods as outlined in the instructions for use (IFU). A NB will review the technical file, including validations, to confirm compliance.
The testing process
The first step of testing is to conduct a gap analysis to help evaluate where deficiencies exist in your product portfolio data. To start, review the technical file for each of your Class Ir devices to help identify missing information or outdated test strategies. Prioritize your legacy devices, as these will be the most time-consuming. Keep in mind that NBs will not take your product’s past performance or reviews into consideration—you’ll need the data to back it up.
If you identify gaps in the data, you will need to run a validation test to rectify this and gather supplemental information. Depending on time constraints and resources required, it might be more efficient to partner with a contract research organization (CRO) or external testing lab. An outside partner will be able to perform the appropriate tests and develop experimental design and validation methods to help ensure compliance with the MDR.
Validation studies
If you determine you need to proceed with validation testing, identify the types of studies necessary for your product or product family. Validation protocols will be developed and customized to your product, its IFU and its worst-case conditions. Here are a few examples of the studies that may be required:
- Cleaning efficacy studies confirm your cleaning process is reliable, repeatable and meets clean endpoints.
- Sterilization efficacy studies are similar to cleaning efficacy studies and are used to verify that the sterilization methods successfully achieve a targeted sterility assurance level (SAL).
- Dry time validations must be provided to healthcare facilities to accompany the steam sterilization cycle.
- Disinfection validations, separate from a cleaning validation, supplement documentation that demonstrates selected disinfectants can reduce microorganisms to acceptable levels on the medical device.
- Support for functionality studies includes exposing devices to multiple cleaning, disinfection and/or sterilization processes.
As you plan for the above validation studies, be aware of the expense and time needed to complete each one. Consulting with a CRO or external lab will be helpful, as they can ensure testing stays on schedule and adheres to the ever-changing technical and regulatory landscape.
It is crucial to remain full steam ahead with your MDR preparations. Since the number of NBs is shrinking, be prepared that those you have used in the past may have limited capacity or be unavailable.
Being proactive and keeping an urgent pace in your preparation of Class Ir submissions will help make the most of the deadline extension. We recommend that you get in touch with your NB – and your CRO or external lab partner, if you are working with one – as soon as possible. If you are unsure about engaging a testing partner, check out “MDR readiness: When to outsource.”
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