If you’re involved in the medical device industry, you’ve probably heard rumblings about the regulatory changes made by the European Union that drastically alter the approval process. Since the early 1990s, the regulatory environment for medical devices sold throughout the European Union has remained largely consistent. Recent events, including a newsworthy episode involving potentially harmful artificial hip implants, have brought scrutiny upon the approval process for medical devices destined for sale in the European market.
As such, in 2017, European authorities announced a fundamental revision of the regulatory framework that seeks to, “support a high level of health and safety whilst supporting innovation.” These revisions are designed to strengthen the approval process, increase regulatory oversight, and help prevent potentially dangerous medical devices from being sold to European consumers.
The high-profile failing described above is unfortunately not the only case where an under-regulated medical device caused adverse effects in the patient population. These examples shed light on the current state of medical device regulation in the European Union and serve to highlight the shortcomings of the previous approval processes.
The previous regulatory framework differed significantly from the regulations put in place by the United States Food and Drug Administration. In the US, clinical and regulatory approval data is made readily available to doctors, their patients, and the broader public. Conversely, in the European Union, that same clinical and regulatory data was held by regulatory authorities over privacy and transparency concerns and was largely unavailable to the general public. Additionally, the criteria for the approval of medical devices was vastly different in Europe compared to those of the United States. For instance, PercuSurge, a company that produces devices for angioplasty procedures, was only required to conduct a 22-person study to get their product approved in the EU, compared to the 800-patient study that was required by the FDA for approval in the United States.
Another of the major regulatory differences lies in the concept of “equivalence.” In the EU, a medical device could be considered equivalent if it was similar enough to another manufacturer’s device that was already being sold. Companies who claimed equivalence didn’t need to conduct clinical trials and were only required to provide limited clinical data to meet the requirements for regulatory approval. The artificial hip implant example described above was the result of false equivalence where the manufacturer used the concept of equivalence to get their product approved for the European market. The company in question had no access to the equivalent product’s technical specifications, meaning there were no grounds for the firm to claim equivalency. Under the new guidelines, medical devices that were previously approved through equivalency will be required to conduct safety trials and post-market surveillance before their products will be allowed to be sold again.
The implications of these revisions are varied and wide-ranging, however, one of the most important is that the approval of medical devices will now be handled at the EU level, instead of letting individual countries set their own regulations. The revisions also give regulatory authorities stricter control of high-risk devices before they’ve been brought to market.
These changes also widened the scope of devices that are required to go through the regulatory approval process to include some aesthetic products that have the same risk profile as other traditional medical devices. Similarly, under previous guidelines, some products used in medical procedures could be classified as medical accessories and thus not be subject to the regulations that governed the approval of medical devices. Under the new laws, these accessories will be considered medical devices and must go through a similar approval process.
The new EU MDR directive also introduces a new classification system for medical devices, based on international guidance, that groups new medical devices by their level of risk to potential patients. Likewise, the revisions seek to improve transparency through the creation of a comprehensive database of information regarding medical devices that are being sold in the EU. Under the new guidelines, medical device companies are also required to track a devices’ component parts from their source, meaning any potential issues related to production can be identified and resolved in a timely manner.
Another main goal of the revisions is to give regulatory authorities greater power to conduct regular checks on device manufacturers and ensure proper testing is being conducted before and after medical devices are introduced to the market. Previous regulations included provisions for random audits, however, under the new regulations device manufacturers must be randomly audited at least once per five-year period.
The new regulatory framework also raises the bar for what can be considered an equivalent device. While the overall extent of the requirements remain unchanged, for devices to be considered equivalent under the new guidelines manufacturers must have a signed contract stating that their devices are indeed similar enough to be considered equivalent. With the new regulations, this requirement ensures that device manufacturers have access to the requisite technical documentation required to prove equivalency.
Product labeling is also poised to change considerably as the new regulations require manufacturers to put product labels in a prominent position more closely reflecting the labeling guidelines put in place by the FDA.
All medical devices sold in the European Union must comply with the new directives by the year 2020 with a deadline of 2022 for in-vitro diagnostic devices.
These revisions to the existing regulatory framework will require a large financial and human capital outlays to achieve compliance by the required date. Estimates suggest that nearly half a million devices will need to transition meet compliance standards under the new regulations. Furthermore, an additional 10 percent of medical devices currently being sold in the European Union may have to be reclassified into another risk category. Devices that require reclassification will require a more significant review, which for many firms, will require additional time and resources to complete the necessary work required to meet compliance standards.
If your company is struggling to prepare for these new regulations, Black Diamond Networks is here to help! We’re a leading provider of experienced technical professionals who specialize in regulatory affairs. We offer a full suite of regulatory and clinical professionals including regulatory affairs specialists, clinical specialists, project managers, medical writers, and many other expert consultants.
Contact one of our account executives to learn more about Black Diamond Networks and how we’re uniquely positioned to help your company achieve compliance with the new EU MDR regulations.