- The European Union has published its first expert panel opinion on the evaluation of a device by a notified body under the new Medical Device Regulation.
- In the opinion, independent experts challenge the notified body's assessment of the Class III implantable device on the grounds that the four-month supporting study was too short.
- The experts want to see an extended study that gathers at least another four months of data on Ivory Graft's Ivory Dentin Graft. The notified body must consider the opinion and advise the manufacturer on possible actions.
The Medical Device Regulation requires panels of independent experts to perform clinical evaluation procedures on certain Class IIb and Class III medical devices. The process involves the appraisal of the clinical evaluation assessment report prepared by the notified body handling the device. The Medical Device Coordination Group shared details about the process last year, but there have been no prior real-world examples of an expert panel in action.
That changed recently with the publication of an opinion by the expert panel on general and plastic surgery and dentistry. The document features an assessment by the screening experts, followed by the scientific opinion of the panel. Both parts of the text raise similar concerns with the evidence in support of the xenogeneic bone graft Ivory Dentin Graft.
Notably, the specialist panel challenged the adequacy of the clinical evidence assessment by the notified body "because of the short period of the study." The experts said that, while the four-month dataset "seems adequate" for morphological investigations such as bone radiodensity, "there was no observation time to demonstrate functionality of newly formed tissue for implant placement."
The experts' conclusion that the clinical data on Ivory Dentin Graft in the filling of extraction sockets to enhance preservation of the alveolar ridge is "insufficient" led to the recommendation that the study be extended to include at least one healing phase, meaning an additional four months of data are needed. Extending the trial would address the experts' request for data on two other indications, namely filling of defects after root resection, apicoectomy and cystectomy, and elevation of maxillary sinus floor.
The applicant only presented clinical data on one indication, leading the experts to state evidence for the other uses is insufficient. The experts downplayed the value of literature searches as evidence as Ivory Dentin Graft is similar but not equivalent to other devices. Ivory Graft compared its device to OsteoBiol Gen Os in its clinical trial. In light of its concerns about the evidence, the expert panel said the post-market clinical follow-up plan needs to be extended to specifically cover the other claimed indications.
The next steps are down to the notified body. Under the terms of MDR, the notified body can choose not to follow the advice of the expert panel in its conformity assessment report, if it provides a full justification, but the feedback could lead to a range of actions.
"The notified body must, if necessary, advise the manufacturer on possible actions, such as specific restrictions of the intended purpose, limitations on the duration of the certificate validity, specific PMCF studies, adaption of instructions for use or the summary of safety and clinical performance or may impose other restrictions in its conformity assessment report," the opinion states.