Class III Medical devices and Implants are some of the most tightly regulated devices in the world. Navigating the complex web of U.S. and EU regulations requires deep experience within the field and a comprehensive understanding of its nuances and subtleties.
The regulatory landscape continues to evolve as the EU moves forward with its new Medical Device Regulations (MDR), which replace the Medical Device Directives (MDD and AIMDD) that governed the industry in the common market since the 1990s. These new, more stringent rules will directly affect many categories of devices. Several devices will be up-classified or fall under new regulations such as cosmetic devices towards getting CE Markand Market Access in Europe.
At TÜV SÜD, Dr. Bassil Akra spearheads many of these fields as the Vice President of the Global Clinical Focus Teams (Cardiovascular, Orthopedic and Clinical). In addition to his internal work at TÜV SÜD, Dr. Akra participates in the European Clinical Investigation and Evaluation working group and several other task forces relating to new guidance documents such as MEDDEV Guidance Documents and Periodic Safety Update Report.
New regulations shift many devices to higher classes
At the middle of 2017, the EU will move forward to publish and put its new Medical Device Regulation into force. Many medical devices previously rated as Class I devices will be moved to higher classes such as Class IIa, Class IIb or Class III levels. With these shifts come a corresponding increase in the level and intensity of quality control and inspection necessary for a manufacturer to bring its device to market in the EU.
Although these regulations won't impact devices sold within North America directly, there will be consequences for many manufacturers, as producing all devices to one standard is generally cheaper than manufacturing to different standards for different markets. In addition, the EU regulatory framework is also mimicked in other regions, particularly in Asia.
"We're going to see a lot more of these devices before they're put onto market," says Dr. Akra. "For manufacturers, the path to market will be completely different. In addition, the new MDR includes requirement that every implant and Class III device shall undergo clinical investigation. The only exception is if the manufacturer has previous sufficient clinical data that shows it is safe, performing well and has a positive benefit risk profile when used as intended."
Manufacturers need to be aware of the layers involved in this change process. Under the new regulatory framework, for instance, joint replacement devices with some exemptions’ will move from Class IIb to Class III.
"These changes will lead the manufacturer to have additional burdens and costs," explained Dr. Akra. "This is in particular due to the fact that every implant and class III devices will be critically scrutinized and will have to submit reports annually such as periodic safety update report, post-market clinical follow-up report, summary on safety and clinical performance report, and finally the whole technical documentation annually in order to validate and assess the evidence included in the continuous reports."
The role of Notified Bodies and clinical evaluations
If new and existing medical devices are not properly recertified in a timely fashion, the consequences could be severe. Unlike Class II devices, Class III devices are not assessed on a sampling basis but individually. In addition, the MDR brings with it no "grandfathered" certifications - every device recognized under the MDD must be newly certified under the new regime. The MDR also grants Notified Bodies an increased authority, including post-market monitoring, which can include unannounced audits, product sample checks, testing and annual reporting.
"In Europe we have the continuous assessment, audit and certification rules," adds Dr. Akra. "Even if the device doesn't change, it only has a limited approval for a period of five years. After that, they have to be re-assessed under the current requirements and by considering the current state of the art towards device extension."
All of this makes Notified Bodies - of which TÜV SÜD is the biggest organization - a vital independent association for medical device manufacturers regionally and globally. The certification process is stringent, but it need not be painful within a qualified and experienced partnership. And it is thought leaders like Dr. Akra who make TÜV SÜD such a valuable resource for manufacturers, regulators and all other parties involved in the process of bringing a medical device from conception to market.
TÜV SÜD is sponsoring a series of workshops entitled “Latest news on the European Medical Device Regulation”. These live, full-day events include technical information, Q&A and networking with TÜV SÜD specialists.
Attendees will learn about the following:
- Overview of the Medical Device Regulation (MDR)
- Impact of the MDR on the conformity assessment process
- Impact of the MDR on the technical documentation
- New clinical and post-market surveillance requirements
- Case study – Medical Device Manufacturer
To learn more about dates/locations and to register, click here.