Testing your medical device properly and preparing a strong regulatory submission is a dynamic yet crucial part of bringing the product to the market. Put simply, the submission stage is not where most manufacturers want to gamble or guess.
That’s where a qualified laboratory testing partner can be useful. It can be invaluable in helping you navigate the ever-changing regulatory landscape and meet the necessary expectations. So, we compiled answers to some of the most frequently asked questions regarding medical device testing and regulatory submissions.
1. How can I minimize delays in the submission review process through testing?
It’s impossible to accurately predict what regulators will ask of you during submission, but you can avoid some of the most common pitfalls if you do your homework and partner with knowledgeable experts. A bit of extra effort upfront can save time and money down the road.
- Use a risk-based approach
ISO 10993-1:2018 sets the stage to thoroughly identify a product’s potential risk starting with chemical characterization. Developing a testing plan to support the safety of your device is not a check-the-box exercise, and test plans need to be justified. With a solid understanding of your device, its intended use, and how the device is manufactured, you can identify potential risks of your device in advance.
- Stay ahead of the standards
Regulatory guidance is continuously evolving. Even if your previous device submissions made it through seamlessly, it is crucial to comply with the most up-to-date methodologies and identify any gaps in what you have versus what you need. Project teams that are unclear on the latest standards should identify partners with current and consistent experience to help navigate the regulatory landscape.
- Provide expert qualifications
In ISO 10993-1:2018 the standard includes ensuring that qualified individuals carry out the biological evaluation, so it matters who you choose to work with. Many regulators request credentials of the medical device evaluation staff to determine credibility and gauge the quality of resulting data. This qualification is most relevant to the toxicology experts involved in your study program. Gather CVs at the onset of work with laboratory testing partners, so the information is readily available for submission.
2. Is there a difference when preparing submissions for the U.S. versus European markets?
Yes. Every regulatory submission, governing body and reviewer is unique, but manufacturers who consider emerging regulatory trends in the early stages can prepare a stronger submission and avoid additional testing or requests for information in the future.
Understanding regulators’ expectations and priorities will help you build a submission that is tailored to the right market. The EU Medical Device Regulation (MDR) is scheduled to go into effect soon, meaning achieving compliance for medical devices across the EU could be a more strenuous effort than it was previously. According to regulatory consultancy The FDA Group, the MDR is four times longer than its predecessor—the EU’s Medical Devices Directive (MDD)—and contains new regulations as well as modifications of preceding ones1.
Also note, the U.S. Food & Drug Administration (FDA) and the EU MDR differ in their approach to assess quality and overall risk profile, device classifications and clinical testing procedures. In addition, devices that were once compliant with MDD may not be under MDR, so working with a lab testing partner that understands the finer points of both regulatory guidelines will be crucial in achieving new approvals and updating legacy ones.
3. Is a pre-submission meeting worth it?
Yes. Pursuing a pre-submission meeting with regulators is a proactive step toward ensuring the viability of your testing strategy. The true value of pre-submission meetings is threefold. They can be used to:
- Clarify final submission expectations
Pre-submission meetings help remove the guesswork. They can determine testing expectations and applicable standards in the market where you plan to submit. With continuous regulatory updates, these meetings can level-set new expectations mid-stream. They are also a great opportunity to identify any missing information prior to submission.
- Improve your planning process
Teams that come to these meetings with specific questions can streamline the planning process and quickly identify areas to focus on and potential pitfalls to avoid. Note, the U.S. FDA will not instruct manufacturers on what to do for next steps; instead, its role is to identify gaps and opportunities for development in their existing plans. This can happen in pre-submission meetings but advanced preparation is key to a successful meeting.
- Refine your testing strategies
Laboratories cannot adjust study parameters after the fact, so using pre-submission meetings to arm them with the most up-to-date parameters can help smooth your submission process. Testing partners are allowed to attend pre-submission meetings to serve as expert counsel, but it is not required.
4. Can I repurpose the strategy from a recent submission package?
Even if your last submission was only a year ago, your technical file likely requires changes and possibly new testing. Relying on past processes and data often results in unforeseen obstacles and may lead to additional information requests. There are several things you can do to minimize questions from regulators:
- Engage a testing partner
Testing partners can help you navigate the submission process and identify potential compliance gaps with current regulatory standards. Even if your previous device submissions passed with flying colors, vetting it against the most up-to-date methodologies helps identify any gaps and identify where new test methods or data preparation must change.
- Anticipate additional information requests
Being realistic and preparing for additional information requests is essential. While it might not be possible to completely eliminate them, planning them into your budget and timeline can help mitigate any delays. Your testing partner can also provide support with responding to additional information requests.
- Prepare for future submissions
The regulatory landscape is in constant flux, and regulatory bodies need more information than ever to assess the safety and risks of a device. Keep a log of the requests during each submission process and share the findings among your team. Detailed notes from past submissions and supporting evaluation plans can help set realistic expectations for future projects.
- The bottom line
Your submission’s success depends on your ability to plan properly, manage resources effectively and meet regulator expectations. A laboratory testing partner can walk you through everything you need to know—including whether a pre-submission meeting is needed—to ensure your submission proceeds without difficulty.
Still have questions? We’re here to help. Reach out to WuXi AppTec Medical Device Testing experts here.
- The FDA Group. (2021, February 16) MDR vs. MDD: 13 Key Changes. Retrieved from https://www.thefdagroup.com/blog/mdr-vs-mdd-13-key-changes.
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WuXi AppTec provides a broad portfolio of R&D and manufacturing services that enable companies in the pharmaceutical, biotech and medical device industries worldwide to advance discoveries and deliver groundbreaking treatments to patients. As an innovation-driven and customer-focused company, WuXi AppTec helps our partners improve the productivity of advancing healthcare products through cost-effective and efficient, socially responsible and sustainable solutions. With industry-leading capabilities such as R&D and manufacturing for small molecule drugs, cell and gene therapies, and testing for medical devices, WuXi AppTec’s open-access platform is enabling more than 4,400 collaborators from over 30 countries to improve the health of those in need – and to realize our vision that “every drug can be made and every disease can be treated.”