The current regulatory environment has created both opportunities and setbacks for medical device companies as they work toward obtaining regulatory approval on their products. On the one hand, the delayed EU Medical Device Regulation (MDR) deadline means that manufacturers have more time to prepare their applications. On the other, the industry at large is responding to a global pandemic, which has strained capacity and led to supply chain disruptions that can affect development timelines.
To streamline the submission and approval processes for devices, regulators from both the U.S. Food and Drug Administration (FDA) and the EU Medical Device Regulation (MDR) are encouraging manufacturers to take on a more active and collaborative approach to their submissions. Part of this effort includes scheduling a meeting prior to submission with regulatory bodies – called a “pre-evaluation meeting” for the MDR or a “pre-submission meeting” for the U.S. FDA – to discuss the device, review testing strategies and connect with the experts on your team. Doing so can help ensure a successful submission, and there are steps you can take to prepare for this essential part of the submission process.
The scheduling of a pre-evaluation or a pre-submission meeting is relatively straightforward. The regulatory body will assign you a timeslot within a month of your request. However, you are only allowed one meeting per device application and it lasts about an hour, so you’ll want to make sure you and your team are ready to make the most of it.
As you prepare for your meeting, it is critical to note some key differences between the U.S. FDA and MDR’s approaches to their assessments. The U.S. FDA emphasizes an experience-based methodology when categorizing risk and device classification. If a predicate device does not exist, the U.S. FDA might decide it has a higher risk classification. Meanwhile, the MDR takes a more hands-on approach when assigning risk, including supplying a classification criteria guide with more than 20 rules. The guide aids in identifying classifications and it underlines the importance of planning ahead.
Before your meeting, familiarize yourself with every aspect of your device, or make sure someone with the proper background knowledge is a part of the meeting. Fully understand its constituent materials and their testing history, along with your development process and know the category and classification of your device. Part of your preparation should be to anticipate what questions the investigators will have for you. They will be reviewing your testing plans, so make sure they are up to date and as inclusive as possible. The better prepared you are, the more successful the meeting will be.
Including your testing partner during the preparation phase can be invaluable. They can be especially helpful when drafting a formal testing strategy: identifying the risk associated with the device, how to meet the identified risks, and specific tests that will be performed i.e. chemical characterization, cytotoxicity, and more. The regulatory bodies will want as much detail as possible, and a testing partner can provide this essential documentation.
A testing partner can also be useful as your team’s go-to expert in the meetings themselves. Testing partners might even be better able to address specific questions or concerns during the meeting. Investigators place a high value on qualified personnel developing strategies (they often want to see the CVs of those who’ve written your strategy) and it is useful to be able to defer to testing partners and their expertise. Some regulators prefer that manufacturers bring their testing partners with them to these meetings. The bottom line is that you should rely on your team and their strengths and know their roles before the pre-evaluation or pre-submission meeting begins – including your testing partner.
By planning ahead and including the essential members of your team, you can come ready for a successful and beneficial pre-evaluation or pre-submission meeting. Doing so will assist in the approval process and prepare you and your devices for successful outcomes.
Contact your testing partner to learn more about how they can help.
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Established in December 2000, 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. 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 4,100 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”.