Expert discusses how to avoid clinical evaluation derailments for medical devices
BARCELONA – Manufacturers should ensure that their clinical evaluations for high-risk devices include a clear statement of the device’s benefit and a well-developed postmarket surveillance plan to ensure smooth notified body review of their submissions, asserted Susan Partridge, clinical regulatory lead at BSI, at the RAPS European Clinical, Risk, and Postmarket Surveillance Conference on 23 October.These were some of the recommendations she shared based on some of the clinical evaluations she has reviewed to support the marketing of medical devices and IVDs under the EU’s Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR).
Matthias Fink, an orthopedic surgeon and senior clinical consultant with the AKRA team, a medical device consultant, noted that there is a “higher focus on the clinical data” compared to the previous directives.
Partridge said the top clinical questions notified bodies have for manufacturers of high-risk devices address the device’s clinical benefit, the safety and performance objectives, the post market plan, equivalence claims, and the summary of safety and clinical performance (SSCP).
She asserted that “it’s clear that the clinical portion of the assessment is a particular pain point for both notified bodies and manufacturers.”
To avoid derailment, she said that sponsors should present a clear picture of a device’s clinical benefits. For example, it is not sufficient to say that the main clinical benefit associated with the use of the balloon catheter is “enlargement of the stenotic portion of the coronary vessel or bypass graft.”
She said that “stating what the device does is not enough and will be questioned to establish the true clinical benefit, and clinical benefit should be the actual positive impact of the device on the patient.”
Sponsors should also have a well-developed postmarket surveillance plan in place. She said that manufacturers often report that they regularly gather information about their medical device from customers, yet this is often done in an unstructured manner.
In some cases, manufacturers did not specify which information they intended to collect about the device. In other cases, these plans often failed to indicate how they would gather data from selected sources, or how they would analyze the collected information.
Sponsor should avoid the following missteps in presenting clinical information: not having a breakdown per indication/variant studied, having complicated summaries that do not disclose or distinguish between sources of data, have missing references, and having no overall summary.
Fink added that the landscape of clinical evaluations is complicated in the EU by the fact that there are numerous parties involved and sometimes differing expectations among the dozens of notified bodies.
