European and US medical device regulations: Two steps ahead or one step behind?


In December 2016, the 21st Century Cures Act was signed into law, $6.3bn in funding was directed towards research and drug development, and increased access to treatments for patients with mental health and substance abuse issues was introduced.

In addition, the law also expedites the approval process for new drugs and devices, mainly by reducing the amount of data required to be submitted to the US Food and Drug Administration (FDA) by medical device manufacturers for the purpose of making decisions.

While the earlier process relied on extensive data mainly gathered from clinical trial results for market approval of the device, new legislation states that a similar approvals should be granted to devices based on real-world evidence. While this switch from a more stringent to a less stringent requirement works well for the medical device manufacturers, there is also a question of what long-term impact it will have on the evaluation of safety and effectiveness of such devices for patients.

The EU commission adopted two new regulations on medical devices in April 2017, which will replace the existing directives. The new rules are aimed at tightening the controls to ensure that devices are safe and effective. While the new rules will only apply after a transitional period, it reflects a different approach to what the FDA is currently embarking on, one that is focused on a more regulated and stringent framework with emphasis on patient safety and public health.

It is clear that the EU commission has taken a stricter take on regulation following the scandal that saw a French company using a cheaper type of silicon in its breast implants, instead of medical-grade silicon. The new regulations promise more scrutiny for aesthetic products, reaffirming the EU commission’s commitment to avoid similar situations in the future.

Rapid progress within the healthcare sector is leading to the advent of new types of products within the area, mostly dominated by innovations within digital health. The 21st Century Cures Act identifies different types of medical device software that are now excluded from the regulatory framework of the FDA. This includes the software such as those that support electronic health records and decision support systems. While this deregulation is aimed at streamlining the regulatory process within the FDA, in light of new regulations that have less-stringent data requirements for market approval of devices, it could be questioned how reliable the original data is, given that the source is also unregulated.

The FDA seems to be steering the ship in the best direction forward, with the Center for Devices and Radiological Health (CDRH) establishing the digital health programme that aims to provide continued regulatory clarity for products based on digital health. The new EU regulations have also tightened the regulations for software platforms, especially those used in digital health applications. It now states that if software affects the use of a device, then the software itself will be classified as a medical device. It is a grey area and one that requires more discussions and consensus between the regulatory agencies, industry, and end users of these devices.

The US and EU are two main markets where stringent medical device regulations of the past have helped each region establish itself as an important market for these devices, both as an importer and exporter. However, at this juncture, these regions are responding to changing market dynamics.

While one region is embracing the change with more compliant adherence to regulations, the other seems to be relaxing the regulations in an advantage for medical device manufacturers. The added regulations may mean more expenses for device manufacturers, something that will have an impact on the cost of these devices, but reducing the regulations can potentially draw into question the long-term safety and effectiveness of the devices.

Irrespective of the region considered, the route to market for medical devices in these regions will also be impacted by the changes in regulations. Only time will tell if these strategies are cost-effective and ones that truly rewarded innovation.