The EU MDR was passed on 5 April 2017, replacing the EU Medical Devices Directive (MDD). The legislation, which will apply from 26 May 2021, was introduced to diminish the adverse health impacts associated with hazardous substances in medical devices.
Medical devices are vital for the health and well-being of patients all over the globe. From smartwatches to pacemakers, the ongoing use of medical devices is integral to the diagnosis, prevention, monitoring, and treatment of a wide range of medical conditions.
The timeline for bringing a medical device to market can average anywhere between three and seven years. To get there, manufacturers must navigate through a complex regulatory framework that has been implemented to safeguard patient safety.
However, the regulations and standards that support this framework are historically outdated, fragmented, and in urgent need of modernization. In a bid to help global manufacturers overcome these issues and improve compliance, European regulators are updating three decades of regulatory legislation.
The updates will see regulators replace a series of existing medical device directives with a more robust, comprehensive set of regulatory guidelines — captured under the EU Medical Device Regulations (EU MDR).
Mitigating risk and prioritizing patient safety
By introducing the EU MDR, industry regulators hope to ensure all medical devices placed on the EU market are beneficial to society while being as risk-free as possible. In other words, it’s about striking a balance between safety and efficacy — helping to roll out medical devices to the right patients as swiftly and safely as possible.
This risk management does not just apply to the medical device itself but to the entire value chain — from raw material extraction to product marketing. In reducing the potential biological risk that medical devices pose, manufacturers will need to consider factors such as placement of the device on the patient (e.g. on the surface of the skin or implanted in tissue) and the duration of contact (e.g. hours/days/weeks).
In section 10.4, the legislation outlines manufacturers’ obligation to report on the chemical composition of their products. This includes verifying the presence of any of 1,200 substances (classified as CMR 1A and 1B) that are limited to a threshold by the EU MDR. If a device contains one of these hazardous substances, manufacturers must limit its content to a safe threshold.
Keeping a finger on the pulse
Another key feature of the EU MDR is that it anticipates further changes to regulations in the future that will likely result from continued advancements in technology and materials innovation. As a result of this iterative nature, EU MDR (unlike prior directives) therefore compels organizations to better understand up-to-date safety regulations — including gleaning a better insight into the chemical properties of materials used in medical device development.
While EU MDR will change how the medical device industry responds to regulation, medical device manufacturers will still be faced with the same concerns — namely, how to accelerate product commercialization, protect brand value, and remain competitive in an increasingly crowded marketplace.
With the introduction of this new legislation, manufacturers need to adopt a more thorough approach to chemical and material characterization. By doing so, they’ll enable the innovation, safety, and compliance necessary to secure market advantage in the sector. That said, certain markets outside the EU may face short-term disruption upon the application of the legislation.
What does EU MDR mean for U.S. firms operating in the EU medical device market?
The EU medical device market is the second-largest in the world after the United States, and the U.S. is its top supplier. U.S.-based medtech organizations therefore need to remain vigilant with the latest developments related to EU MDR. According to United States International Trade Commission (USITC):
"U.S. medical device manufacturers are the biggest suppliers of the EU’s medical device market, accounting for close to two-thirds of their imports in recent years and 41 percent of medical device patent filings with the European Patent Office. The new regulatory structure created by the MDR will likely create a number of challenges for U.S. medical device manufacturers, including additional compliance costs, regulatory uncertainty, and the classification of new products as medical devices."
Previously, the EU boasted the world's shortest approval times among leading markets for high-risk devices. This has made it the primary destination for U.S. medical device exports, with U.S. companies typically amassing one-third of their revenue from the EU. However, this stringent new legislation may produce new delays in approving medical devices for sale in the EU market.
While the EU MDR will provide extra safety for EU patients, the USITC warn that "extensive delays in the EU could require U.S. firms to pursue other market opportunities or incur additional operational costs." In any instance, it is vital that U.S.-based manufacturers keep a finger firmly on the pulse of developments across the Atlantic.
Why EU MDR matters
In 2021 and beyond, we can expect to see major advances in materials analysis and testing technologies. Together, these developments will accelerate the discovery of new polymers that can be integrated into the design of next-generation medical devices.
Supplier management will also be key. By first cultivating strong, mutually beneficial relationships with suppliers and then collecting relevant chemical testing information, manufacturers will be able to choose more safe, suitable, and cost-effective materials during product development.
The medical device landscape is in a constant state of flux thanks to ongoing technological innovation and evolving regulation. The EU’s first major update to medical device directives in three decades will see a heightened emphasis on safety. By modernizing and harmonizing regulatory requirements across different regions, these emerging regulations will encourage an industry-wide risk-management approach towards defining testing plans for specific devices.
Manufacturers that sell to or within the EU market will be compelled to:
- Gain a thorough understanding of chemical and materials testing requirements
- Generate robust and appropriate biological testing plans
- Identify unknown extractable and leachable components
- Improve chemical and material characterization to establish product equivalence
- Ensure medical devices are durable and ready to deliver benefits for patients
Once implemented, compliance of the new regulations will be enforced through prosecution and penalties (including fines and, in severe circumstances, imprisonment). Poor adherence to regulatory requirements will also lead to poor brand reputation, as well as potential loss of access to materials, loss of investment, and/or loss of market share.
Though short-term disruption may follow the rollout of EU MDR — particularly for U.S. manufacturers — ensuring that products are certified and fully compliant will prove critical for manufacturers’ credibility and profitability in the long term.
The EU MDR will apply from 26 May 2021; one year after initially planned (the delay owing to COVID-19 disruption). Until 25 May 2021, the EU Medical Device Directive (MDD) and national laws will apply. If you have any questions about EU MDR, please get in touch here >