TRIQ, Medical Devices & MDR

Medical Device Clinical Investigations, according to EU 2017/745 MDR are the main focus of TRIQ.

What are Medical Devices?

Medical Devices are classified according to their intended use and body contact duration. The range is immense; for example, ECG electrodes, catheters, passive implantable devices such as heart valves, up to active implantable devices such as ICD, CRTD, Neurostimulation and deep brain stimulation devices. There are also combination devices where a pharmaceutical agent is introduced to the body by a medical device, for example, insulin pumps.

What are the challenges associated with MDR?

Not only do the clinical investigational aspects play an important role in medical device trials, but the challenges associated with EU 2017/745 MDR are extremely complex and often underestimated by CROs new to medical devices. Increasingly more devices have innovative aspects that require in-depth technical understanding and experience with the application, for example, an in-depth understanding of how to classify software/hardware combinations, are they diagnostic or therapeutic? Are there requirements for diagnostic imaging and OR requirements for implantable device procedures, including OR procedure support, post-OR programming and follow-up?

Choose your partner carefully.

TRIQ and its employees have decades of experience in the most complex medical device trials. TRIQ has completed MDR-compliant medical device trials.  We know the challenges and can guide you through the classification, strict regulations, submission,  trial initiation and efficient trial management. In addition, we can support you with experienced field clinical engineers and proctors for implant training and procedure support if required.