Medical devices and the medical device industry play a crucial role in ensuring people’s health and well-being. Compared to the pharmaceutical world, the regulation of medical devices is relatively novel and comparatively more complex. In the US, drugs have been regulated since 1906; medical devices only since 1972. The first European drug regulations were published in 1965; the regulation of medical devices didn’t start until 1990.
There are about 20,000 approved prescription drug products in the US, but there are hundreds of thousands of different medical devices. They range from the very simple (e.g., bandages) to the very complex (e.g., implantable cardioverter-defibrillators). From a regulatory perspective, we are still learning the most effective and efficient way to manage medical devices.
Regulations in the European Union
The evolving regulatory landscape is most evident in the changes happening in Europe. In response to flaws that allowed, for example, the PIP breast implant scandal and metal hip implant safety problems, European regulators introduced two regulations: the European Union (EU) Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), applicable to in vitro diagnostic medical devices. The regulations are intended to address “substantial technological and scientific progress” in the medical device space.
A significant difference between the US and EU medical device regulatory models is related to market access. In the US, once the Food and Drug Administration (FDA) has determined that a device can be marketed, a manufacturer does not normally need to submit further premarket information to the FDA for that device unless it changes significantly. In the EU, however, a device’s market-access certification expires every five years and must be recertified to continue to be marketed. With the new EU regulations, there is more emphasis on the initial and ongoing generation of clinical data supporting medical device marketing. Ironically, this has most significantly affected manufacturers of devices that have been on the market for many years. Prior to the EU regulations, these devices did not need to generate new data to support their continued marketing.
The EU regulations also increase the regulatory requirements and overall scrutiny that notified bodies undertake prior to device certification. For startups and smaller companies, this creates significant barriers to entry. This is particularly true with respect to clinical data – as the new regulations do not generally allow the use of clinical data from comparable (equivalent) devices, which requires each company to create its own data. The EU regulations also increase the focus on postmarket surveillance and a company’s ability to continuously monitor and respond to problems.
The Global Impact of MDR
Prior to MDR and IVDR, many medical device companies distributed their products on the European market first because it was easier to obtain a CE marking — certification that a product meets EU health, safety, and environmental requirements — than it was to obtain FDA market access. Once manufacturers developed a better understanding of the device, they would approach the FDA for market access. However, the new Medical Device Regulations are causing companies to change their approach as these regulatory obstacles restrict access to the European market.
Critics of the MDR argue that these changes may negatively affect new technologies and products in Europe. Since other markets have an easier certification processes, it makes more sense for foreign companies to launch and test new products in the US, then bring them to the EU.
The Future of EU Medical Devices
European medical device regulations play a pivotal role in shaping the global medical device community, but European stakeholders face challenges they weren’t prepared for and fear for the future of the industry in general.
The emerging digital health landscape adds complexity to regulatory frameworks because there are gaps in understanding how these rules should apply.
As the global medical device industry continues to advance, the EU may find itself reassessing its regulatory framework. Increased collaboration between regulatory authorities and other stakeholders will be crucial for future innovation, patient safety, and the well-being of the European economy.
By: Jay Crowley, Vice President of Medical Device Solutions and Services at USDM Life Sciences
