For a long time, nothing has been heard about the consultation process for clinical investigation of high-risk devices. As a reminder, Article 61(2) of the MDR states that for all Class III devices and Class IIb active devices intended for the administration and/or disposal of a medicinal product, the manufacturer may consult the expert panel established under Article 106 of the MDR to review the clinical development strategy or proposals for clinical investigation prior to its clinical evaluation/investigation.
As regards the subsequent clinical investigation assessment procedure on the notified body side, the involvement of the expert group concerns an almost identical group of devices (for Class III the obligation is narrowed down to implantable devices). The consultation of the expert group is thus primarily intended to assist manufacturers and subsequently support for the notified bodies.
Last year, things finally got moving and, as part of an expanded mandate in the area of crisis preparedness and crisis management of medicinal products and medical devices, the European Medicines Agency (EMA) took over the coordination of the Expert Panels on Medical Devices on 1 March 2022. Currently, as of 27/02/2023, the EMA has launched a pilot project to provide scientific advice on the intended clinical development strategy. From this date, manufacturers can also send written requests for participation. The first five applications will be selected in April, and the pilot is ready to receive a total of 10 applications. Expert panels will provide free advice to the selected applicants on clinical development strategy and/or clinical investigation design. The pilot will prioritise certain types of medical devices:
1) Orphan devices and paediatric devices
2) Devices that address medical conditions that are life-threatening or cause permanent impairment of physical function and for which medical alternatives are currently inadequate or pose significant risks
3) Innovative devices with a potentially significant clinical or health impact.
This is good news for all manufacturers developing devices falling into this group, as the EMA will allow them to benefit from free highly qualified clinical advice. It will also help them to align with the view of European clinical experts and, subsequently, with the view of the notified body that will certify the device. Let us hope that the capacity of the EMA expert panels will be sufficient. For small and medium-sized innovative manufacturers in particular, this will be a great help.
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