Regulations for medical and diagnostic devices are changing in tune with advances in technology, new and innovative medical treatments, and the need for more effective diagnostic practices. Infiniti Research expects the market for medical devices to experience positive growth in the coming years as new rules and regulations eliminate counterfeit and dangerous products, increasing consumers’ trust and allowing established and reputable vendors to flourish.
New European Union regulations on medical devices will help to modernize public health and increase patient safety and outcomes. First proposed in 2012, the new rules (titled “the EU Medical Devices Regulation and In-Vitro Medical Devices Regulation”) came into effect in early April of this year following trilogue negotiations between the European Parliament, European Council, and European Commission. They will fully apply after a transitional period of three years for medical devices and five years for in-vitro diagnostic devices.
These regulations are replacing and modernizing three directives pertaining to in-vitro diagnostic products and medical devices with an aim to ensure both patient safety and product innovation. Both of the new regulations will improve the quality and safety of medical devices, increase market safety and monitoring, and will make important information about vendors and medical device products more easily available for patients to access. They now allow for random inspections of producers’ facilities after devices have been placed on the market, require clinical evidence of medical device safety to be provided by manufacturers, introduce an "implant card" for patients that will enable healthcare practitioners to track and monitor which product has been implanted, and have been expanded to cover aesthetic products—such as colored contacts—that have the potential to harm consumers.
How Can Infiniti Research Help?
As technological standards and regulations for the healthcare industry and medical devices continue to change, it can be difficult for vendors to anticipate demand and prepare for new challenges. Market intelligence can be extremely beneficial in allowing vendors to understand how new laws will affect their business, strategize to overcome major obstacles and challenges, and to identify key competitors. It also enables them to adhere to region-specific regulations in each country they do business in, ensuring the safety of their customers.
Infiniti Research was recently approached by a global manufacturer and supplier of medical devices to assess the market landscape for radiography systems in the US. The insights provided by Infiniti’s analysts helped the client to gain a comprehensive understanding of the distribution structure for floor mounted radiography systems, as well as the growth strategies followed by market leaders.