Significant changes are ahead for medical device manufacturers. The EU’s Medical Device Regulation (EU MDR), which is set to replace the current directive for the regulation of devices in 2020, will introduce significant regulatory changes that will impact all organizations producing or supplying medical device products to Europe. Ahead of the American Medical Device Summit 2019, Generis Group spoke with Yashesh Rawal, Regulatory Affairs Specialist from MAE Group, to discuss the major challenges of the new EU MDR, its impact on medical device manufacturers, and how organizations can prepare to ensure a smooth transition.
Read More →Ask the Expert: EU MDR
HCL hosted a Lunch & Learn Roundtable Discussion at the American Medical Device Summit 2018 last month in Chicago, IL. The session, “Ask the Expert – MDR and Lifecycle Management”, was led by Associate Vice President, Hilde Viroux. Hilde addressed questions surrounding the uncertainty of EUDAMED and UDI, the transition period, and how to obtain compliance. This is an excerpt from an interview Generis Group did with Hilde Viroux, AVP, Regulatory of HCL, America Inc. prior to the American Medical Device Summit 2018. “What are some of the biggest challenges in the new MDR that will impact device manufacturers? There are a lot of changes in the EU MDR that impact device manufacturers. Generating clinical data for all devices, developing the required reports and updating technical files to be compliant with Annex II and III is where most of the budget will typically go. In addition, there is the requirement to trace hazardous substances in devices and identify them on the label. The new regulation also requires manufacturers to set up a proactive approach to following the performance and safety of the device throughout its lifecycle.”
Read More →Reduce Supplier Risk, Reduce Organizational Risk
Risk is a major focus in most businesses today, regardless of industry. In the past few years, the Life Sciences have seen a steady rise in supply chain issues resulting in lost market caps, recalls, regulatory fines, and other financial impacts valued in the billions of dollars. The Medical Device Industry is no exception to this reality; if the industry wants to improve patient outcomes, then it has to manage risk. According to Pilgrim Quality Solutions, one of the largest sources of organizational risk is dependence on third-party suppliers. Today’s global economy has added complexity to supply chains, and longer supply chains are making it increasingly difficult to manage suppliers, and in many cases, suppliers’ suppliers, thereby increasing overall risk. The plethora of regulatory requirements placed on Medical Device organizations, including the updates to ISO 13485:2016, reflect this new reality.
Read More →Track and Trace: A Step-by-Step Guide to Implementing An Effective Program
Although the universal standard for pharmaceutical track-and-trace solutions has yet to emerge, the California Board of Pharmacy’s ePedigree requirements are currently driving action in efforts toward implementing serialization to provide supply chain integrity to the public. While several states are actively pursuing similar legislation, California’s pending requirements are the most demanding since they track product to the smallest saleable unit level. Enforcement of the ePedigree legislation, combined with the accelerated pace of regulatory involvement worldwide in serialization and track-and-trace means that it is now vital for the industry to accelerate its efforts to put compliance measures in place.
Read More →Global Regulatory Intelligence: Evaluating the Developments to the EU MDR
Is your company prepared for the new EU MDR? Michael Santalucia, Vice President of Global Regulatory Affairs for Terumo BCT, is responsible for managing the global regulatory affairs function regarding the development and execution of product submission strategies for the company’s medical devices, regulatory compliance requirements, and industry advocacy. As medical device companies face large regulatory challenges to comply with the new European Union Medical Device Regulation (EU MDR), we sat down with Michael Santalucia to learn how Regulatory Affairs organizations are evolving along with global regulations, what Terumo BCT has been doing to comply with EU MDR, and how members of the medical device industry can stay informed. “The EU MDR is arguably the most important legislation to affect our industry in the last two decades. Because of the impact this will have for any firm with CE marked devices, it is essential to have someone in the organization that can provide the company with advice and guidance to the requirements that have been established and those that are yet to evolve.”
Read More →In the Global Life Sciences Market, What You Don’t Know CAN Hurt You
The global life sciences market is witnessing an unprecedented pace of change across pharmaceuticals, medical devices, and biologics. It’s the new normal as trends like big data, the Internet of Things, increasing supply chain complexity and the advance of biosimilars create new opportunities – and challenges – for life sciences companies. As regulators around the globe scramble to stay abreast of these trends, they are making important and often major updates to directives. Quite often these directives are not coordinated between markets, creating a patchwork compliance landscape to be navigated. If you are involved in your company’s quality, regulatory surveillance, compliance, or knowledge management efforts, the following questions are for you: Do you have frequent (i.e. at least monthly) conversations with the regulators in the markets where you manufacture AND sell? Does your company have the expertise to predict and interpret regulatory directives? Do you have reliable methods of disseminating information on the impact of regulatory directives to your clinical operations teams? How does your organization remain aware of and respond to GxP actions, import alerts, or other market actions against other companies in your industry?
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