The European Union’s Medical Device Regulation (MDR) is a complex regulatory framework created to put in place rules and requirements in how medical devices are designed, manufactured, and marketed. Also known as Regulation (EU) 2017/745, it supplants the Medical Device Directive (MDD), which was introduced in 1993. This EU law legally mandates all EU member states to ensure patient safety, product transparency, standardization, harmonization of disjointed rules, post-market surveillance, innovation, and robust market access controls.
The MDR is mostly welcomed but, inevitably, there are criticisms against it. Some industry players describe it as “challenging,” especially for non-EU medical device manufacturers that have to implement changes for their EU-bound products to comply with the MDR. Also, some products that were already compliant with MDD may not align with the MDR requirements.
It is easy to see why the MDR is necessary, but it similarly makes sense to try to understand the contentions. After all, the medical and electronics industries are already heavily regulated in most parts of the world. There are fears that regulation may stifle innovation.
The case against singular regulation
In Switzerland, the medical industry association Swiss Medtech called for authorities to allow access to medical devices that have not yet been approved under the EU MDR but have already passed US FDA approval. Since the MDR took effect, some medical device manufacturers have decided to abandon some product niches because of the complexity and costs of compliance. That’s why the medtech industry is asking for the government to look at the possibility of having FDA approval as an alternative to MDR in some cases.
This may sound like a sneaky attempt to skirt EU regulation, but industry players reason out that Swiss patients are deprived of access to useful products because of regulations some deem to be too onerous or costly for manufacturers. What makes American patients different from European patients that the former are allowed access to FDA-approved products but not the latter?
The purpose of MDR medical device regulations is to ensure patient safety and product effectiveness. These goals are not that different from what the US FDA seeks, and there are no authoritative studies that show significant differences in safety and effectiveness between medical devices that comply with MDR or those approved by the FDA.
Swiss Medtech lauds the goal of ensuring product safety and effectiveness in the European Union market. However, the association points out that having too many regulations or requirements makes it extremely difficult for valid innovations to become accessible to Swiss people. Instead of promoting health and safety, regulations may serve as hurdles in ensuring patient well-being and access to more effective and cost-efficient products.
There is a clamor for flexibility when it comes to medical device regulation. Industry players are not asking for the elimination of rules and standards but for sensible compromises or adjustments to ensure patient safety without completely preventing access to other products that have been proven safe and effective based on other regulations.
Why compliance can be difficult
There are many reasons why companies have a hard time complying with MDR. It would be unfair and inaccurate to characterize appeals to relax or adjust regulations as greed or an attempt to maximize profits and reduce expenses. Here are some of the most important concerns manufacturers have.
Continuously growing complexity of devices - Medical devices become more complex and sophisticated with the incorporation of new technologies. This results in changes that can make it difficult for companies to completely document functionality and account for the potential cyber risks. It also makes threat monitoring more challenging. Keeping up with the complexity to ensure compliance entails additional costs, something not many manufacturers cannot afford.’
Interconnectivity and interdependence among devices - In addition to the growing technological complexities, the inevitability of interconnecting medical devices also makes regulatory compliance a tall order. Device interoperation means that manufacturers also have to take into account the risks that emerge when their products operate with others or become integrated into a bigger ecosystem of medical hardware and software.
Mass scale - From implants to wearables and embedded devices, the number of connected medical devices deployed at present can be overwhelming. One report says that there are around 20 connected devices in an average hospital room. Medical device manufacturers sell myriad products to healthcare institutions and individual users so that they are no longer able to properly keep track of what they have sold. They have a hard time complying with the MDR’s post-market monitoring requirement and plan of action. Also, updating device firmware can be a major chore.
Differences in laws and regulations - Another problem in complying with regulations is the existence of different legal requirements, rules, or guidelines in different countries. Some of them may be in conflict with each other. It is not easy bringing products to Europe and modifying them to comply with MDR. That’s why some manufacturers prefer to go elsewhere or stop their operations in Europe.
Rapid changes in technology - Technology advances at such a fast pace that may make it necessary to implement changes in processes, systems, and other technical aspects to continue aligning with regulatory requirements. Sometimes, manufacturers avoid updating to new tech because the regulations do not cover the new technology yet.
Inherent bias for large and established corporations?
Some businesses argue that existing regulations tend to favor large multinational companies because they have the resources to keep up with the costly requirements. Compliance usually goes beyond the product itself. The process typically requires more expenditure to support new processes and hire more people, like in the case of conducting post-market monitoring. Small companies do not have free funds to readily respond to MDR requirements.
It is understandable why some argue that medical device regulations may stifle competition and result in the suppression of innovative products. In some cases, small companies spend so much on regulation that they no longer have enough funds to pursue innovation or novel ideas.
The path forward: collaboration and innovation
Nevertheless, it would be unfair to accuse the European Commission of blatantly favoring large medical device manufacturers. Smaller companies can work together to address regulatory issues that appear antithetical to fair competition and innovation. Businesses, healthcare providers, regulatory bodies, and even consumers can work together to identify problems in regulation that may be depriving consumers access to safe and innovative devices, exacting unfair advantages to certain groups, or preventing innovative ideas from flourishing.
Also, businesses can work together to share new information or insights on how they can meet regulatory requirements as efficiently as possible. For example, some devices may not require an overhaul or massive changes to become compliant with security requirements. It may be enough to deploy a security and observability platform to oversee devices and provide deterministic protection. This is something manufacturers may only learn about if they work together and assist each other in weathering the challenges of increasing industry regulation.
In conclusion, there’s no doubt that EU MDR plays a vital role in establishing a robust healthcare technology landscape even though it may pose considerable challenges to some industry players. That’s why it is advisable for all stakeholders to work together, raise issues, discuss solutions, and propose improvements to regulations for everyone’s benefit. Regulators need to take patient safety, product effectiveness, access to devices, and innovation into account, but they need sensible inputs from manufacturers, healthcare providers, and consumers in the process.
