High risk devices

Thanks to the MDR, many devices in higher risk categories are controlled much more rigorously than before. Implantable devices cannot be introduced to the market under the new EU Regulation without direct clinical evidence demonstrating compliance of safety and performance. Accordingly, all manufacturers who produce such devices are obliged to create clinical data for proving conformity and thus for legally marketing these devices. According to the MDR, clinical data can come from several sources:

  • clinical investigation(s) of the device concerned, 
  • clinical investigation(s) or other studies reported in scientific literature, of a device for which equivalence to the device in question can be demonstrated, 
  • reports published in peer reviewed scientific literature on other clinical experience of either the device in question or a device for which equivalence to the device in question can be demonstrated, 
  • clinically relevant information coming from post-market surveillance, in particular the post-market clinical follow-up;

In our fictitious example, we would like to demonstrate the difficulties that may arise. These are issues that all companies producing such devices should expect.
A recent assignment aimed at the certification of new traumatological implants. These implants, although they are well-established devices, were Class IIb implantable devices according to the MDR, which requires clinical data from clinical trials performed under the responsibility of the sponsor to verify their conformity. Many manufacturers are reluctant to accept this due to the significant expenses and the prolonged clinical investigation(s).

During the transition to MDR, many manufacturers had to face the fact that collecting clinical data for each one of their irrationally wide range of products simultaneously is an almost impossible task. Because of this practical reason we recommend product portfolio optimization, in which we encourage manufacturers to select the most important products for their operation and prioritize the clinical data collection necessary for the conformity assessment of these devices.

We have also followed this path with the traumatology implant manufacturer in our example, and after necessary rationalization of the product portfolio, we have prepared the clinical investigation plan in accordance with ISO 14155:2020 requirements. A clinical trial designed and performed according to the requirements of the standard ensures that the data collected support the compliance of devices with high evidence content in a credible manner.