## 6 Discussion
Therefore, it will be necessary to understand whether every part of the entire process represents a risk or not for the safety of the implant. By doing so, setting up a bundle of tests to evaluate standardized and not-standardized features will be required. Some of these tests are related to the geometry while others arefeasible on samples such as the evaluation of material properties, porosity, and biological inertness. On the other side, shape-specific assessments will be necessary to investigate all the features that vary according to a patient-specific shape, including support generation analysis and biomechanical FEM evaluation. For instance, considering a TMJ implant, a thin surface will necessarily be subject to greater stress than a thicker one, and might therefore require some adjustments in terms of widening its surface or modifying its topology [35]. However, the regulation also introduces new procedures involving an expert panel, consisting of \"advisors appointed by the European Commission on the basis of up-to-date clinical, scientific, or technical expertise in the field\", which will be required to scrutinize the clinical evaluation reports for class IIb and class III devices in compliance with a notified body. Additionally, the expert panel will provide guidance for manufacturers in order to comply with the regulation [36]. Communication between clinicians, surgeons, and engineers might be improved by creating laboratories within hospitals where synergistic interaction between different professionals takes place, including discussion of clinical cases, where engineers might learn more concepts on the biology of diseases and the phases of surgery, and design of implants, where conversely surgeons might learn from the experience of engineers and both figures might cooperate to develop highly innovative and effective devices. The adoption of the novel MDR will introduce profound changes in the field of CMF implants and will deeply affect medical manufacturing. A possible drawback might be the reduction of the number of companies and the variety of devices that today European CMF surgeons can have in their inventory, and in the first instances this might prolong delivery time of devices  
However, we expect the benefits will exceed by far such initial limitations. The entry into force of the novel MDR will have a positive impact on broadening our cultural horizons as it will represent a consistent scientific impulse for novel clinical and engineering investigations [37]. Surgeons will potentially be required to draw up new studies on devices compliant with the novel regulations and will necessarily interact with engineers to fulfil all possible vulnerabilities emphasized by the risk analysis. For these reasons, the collaboration between CMF surgeons and engineers in both computational, biomechanical, and clinical investigations concerning implantable devices is going to be critical in the years to come. As a result of clinical investigations, an increasing amount of data will be available on the European database on medical devices (EUDAMED), which will allow a prompt and easy identification of devices to both clinicians and manufacturers, with univocal nomenclature, and will contribute to the development of big data knowledge on medical devices, leading to further investigations and improvements [38]. On the other hand, reviewing our past clinical experience in light of the MDR will emphasize criticalities that were not addressed, introducing an ethical reflection on what we have done before and on responsibility attribution. In summary, we hope that this regulation will provide an even stronger impulse to closely interact with engineers and to educate the surgeons of tomorrow.