When it comes to medical devices, how can policymakers and regulators protect patient safety without hindering innovation?
It starts with recognizing that in vitro diagnostics (IVDs) present fewer risks to patients than other types of medical devices. We believe regulation policies should accommodate this important distinction to avoid delaying future breakthroughs.
We are starting to see risk-based regulation unfold in the EU now with the new Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). Built from the understanding that all medical devices are not the same, the new EU regulations modernise the rules with a risk-based approach. As such, EU leaders and regulators are well-positioned to lead the way for other countries. Secondary legislation on the MDR and IVDR is still being written, however, so discussions like these remain critical.
To understand why new regulations are needed that support growth in IVDs, take a moment to consider their overall impact on healthcare:
Today, many people are thriving years after being diagnosed with some of the world’s biggest killers, such as heart disease and cancer, as well as infectious diseases like HIV and hepatitis. Much of that progress has been supported through IVD innovation, which enhances doctors’ ability to act on the right information at the right time.
What can samples from the body reveal about a person’s health?
IVDs can spot early warning signs and individual risk factors, creating new opportunities for prevention and early intervention. Some IVDs extend beyond the laboratory, hospital or doctor’s office, empowering patients with chronic diseases to self-monitor and manage their own conditions.1
While IVDs support clinical and personal decision making, they do not directly drive health outcomes. Unlike other medical devices that provide therapy, most IVDs never even come into contact with patients.
Considered the “silent champion” of healthcare, IVDs are extremely valuable resources for disease prevention, detection and management. They influence roughly two-thirds of clinical decision making while accounting for just 2% of healthcare spending.2 As an industry – manufacturers, healthcare professionals and regulators alike – we must not understate or overlook the power of IVDs in the fight against disease worldwide.
The IVDR in the EU uses a risk-based approach, and the time has come for the world to follow suit. Failure to do so will slow commercialisation of new IVD technologies, ultimately inhibiting the ability to continuously improve diagnostic capabilities across the globe.
British In Vitro Diagnostics Association (BIVDA). “The Value of IVDs: The contribution of the in vitro diagnostics industry to patients, the NHS and the UK economy” (2017).
Rohr, Ulrich-Peter, et al. “The Value of In Vitro Diagnostic Testing in Medical Practice: A Status Report.” PLOS ONE 11(3): e0149856 (2016).