Recent changes in the European Union's (EU's) Medical Device Regulations have affected healthcare legislation across the globe, and the demand for people to fill regulatory affairs jobs continues to grow.
Here's a closer look at the impact of the EU's Device Regulations.
What Brought About the EU's New Device Regulations?
According to a recent report from BSI Group, the new regulatory framework for medical devices began as a modest update to existing directives. However, several highly publicized issues with high-risk devices in the EU market led the European Commission to propose dramatic revisions. The changes will affect both Medical Device Regulations (MDR) and In Vitro Diagnostic Devices Regulations (IVDR). With these revisions, the Commission seeks greater centralization and pre-market controls for controversial or risky devices.
These revisions to the regulations are set to bring important changes to all companies in the medical devices field. As a result, qualified regulatory compliance professionals are needed to help ensure companies comply with the new regulations in a proactive and timely manner.
The Scope of the EU Device Regulations
The BSI Group report states that proposed revisions to the MDR will significantly extend device classifications to include questionable or borderline devices, such as contact lenses, cosmetic implants and invasive laser equipment. Such devices don't necessarily have an intended medical purpose but will still be regulated as medical devices. The entire classification system for medical devices will also be clearer and streamlined.
The majority of the features for the revision proposal to the IVDR are shared with the MDR revisions. These include both a new supply chain structure and a central database called EUDAMED, which will be used for both classifications of device regulation.
Additional important developments and changes to the IVDR include a new risk classification system along with greater requirements for clinical performance studies and clinical evidence before companies can obtain certification for devices.
Impact on the Clinical and Regulatory Environment
The report from BSI Group also discusses the impact of the new device regulations. In addition to dramatic changes in device classification and supply chain procedures, the proposed revisions to the MDR and IVDR will require medical device companies to be more vigilant about clinical testing and regulatory compliance.
In the IVDR revisions alone, there will be a quantum leap in the number of devices requiring a notified body certification — from 10 to 20 percent under the current directives to 80 to 90 percent under the new regulations. These requirements will also extend to notifications for a centralized database for clinical trials, extending clinical investigation requirements and ensuring consistency with Good Clinical Practice (GCP) standards for medical devices for both MDR and IVD device regulations.
Finally, because the EU does not allow for the grandfathering of medical devices, all devices must comply with the new regulations in the timeframe specified by the laws.
Implications for Regulatory Affairs Professionals
The new EU regulations will have a significant impact on many types of healthcare companies, particularly medical device companies. Because the laws specify a timeframe by which medical device manufacturers must comply with regulations, these companies must invest in professionals with knowledge of regulatory affairs, GCP and clinical investigation in a timely manner.
People in these positions will be responsible for verifying regulatory compliance for existing and new medical devices, and for communicating with authorities and notified bodies to obtain certification for the devices. The increased career opportunities in regulatory affairs will extend globally, as the EU regulations will also affect U.S. companies that sell medical devices to world markets.
Why Choose a Master's in Regulatory Affairs Program?
The George Washington University's (GW's) Master of Science in Health Sciences (MSHS) in Regulatory Affairs curriculum is designed to give students the skills and education they need to improve health standards in today's domestic and international markets. Developed in collaboration with regulatory affairs professionals and leading government agencies, this program prepares students to excel as regulatory affairs professionals and become innovative leaders in the exciting field of regulatory health science.