Do you have the capabilities to conduct chemical characterization, toxicological risk assessments and biocompatibility testing in-house?
MDR requires that medical devices undergo a complete biological risk assessment to evaluate chemical, toxicological and biocompatibility conditions before they are approved for market. When developing a test plan, look for a partner that offers all three analytical tests under one roof. A lab that is skilled in all areas and uses highly sensitive analytical methods increases efficiency and helps address all biological endpoints, while minimizing room for error between tests. Working with a partner that doesn’t have all of these capabilities may leave you with no choice but to piecemeal your testing, which could risk miscommunication between parties, loss of information altogether, increased costs and longer timelines. Given the looming deadlines, there is no time to spare.
What is your track record for complete identification?
MDR will place increased emphasis on the importance of chemistry and toxicology. For this reason, working with a lab that specializes in complete chemical characterization will yield the best results. Ask how long they have been conducting extractable/leachable (E/L) studies and how sensitive their analytical methods are. It may be a red flag if their test methods can’t detect chemicals above the analytical evaluation threshold (AET). If a lab doesn’t use proper methods or equipment, they may not be able to provide the right data for a toxicologist to fully assess risks. Unidentified chemicals or incomplete risk assessments will endanger your entire submission package. You should look for a lab testing partner staffed with experts who can demonstrate a track record of regulatory success.
What is your approach to reporting unknown chemicals? How often do you report unknowns?
Complete chemical characterization requires identification of every chemical compound in your device found above the AET. While there are commercially available libraries that can help identify some chemicals present in extracts, they are not necessarily reliable in every circumstance. Reporting unidentified compounds can result in an unfavorable risk assessment, which could send you to the back of the line for another round of testing. Having to retest products increases cost and lead times. Ensure your partner has the ability to identify every compound the first time around.
Do you offer follow-up support once a submission is ready for regulatory approval?
While the testing process is of the utmost importance, seeking out a partner that also provides post-submission support ensures everything runs smoothly from start to finish. If regulators have questions or ask for additional information, your partner should be available to provide guidance. When it comes to MDR, partnerships shouldn’t end until regulators deem your submission approved and products ready for market.
How does your staff stay up-to-speed on the changing regulatory expectations?
You will want to work with a lab testing partner that is staffed with experts who sit on regulatory committees, are in-the-know with the evolving regulatory landscape and have been doing chemistry, toxicology and biocompatibility on medical devices for several years. Do your due diligence in learning about a lab or CRO’s involvement with regulatory bodies before inking any agreements, so that you can be confident in your submission package.
These questions will put you on the right path to gauge whether a potential testing partner is capable of meeting your needs. To learn more about how to get the most out of your testing services, read “How to maximize your lab partnership: Details pay dividends.”
WuXi Medical Device Testing offers testing services in St. Paul, Minn., Atlanta, Ga., and Suzhou, China.
