New Global Compliance Requirements Will Impact Medical Device Industry

The medical devices and diagnostics (MD&D) industry is on the verge of disruption, as new global compliance requirements are set to take effect. In March 2019, the 2016 revision to ISO 13485 will require the incorporation of risk management into every aspect of the quality management system. Also, the European Commission ratified new medical device regulations (MDR) for all European member states, while FDA released more than a dozen new medical device guidance documents in 2016 and 2017 that set new expectations for risk assessment. As a result of these changing regulations, MD&D companies are urgently working to get ahead and update their operating processes. This means finding ways to increase operational visibility internally and externally, enable transparent content and data management across all functions, and improve efficiency—especially in clinical, where the number of studies is expected to increase dramatically. New Regulations Create Heavier Burdens in MD&D The new FDA 510(k) requirements for device clearance will make the submission process longer and more involved. Also known as Premarket Notifications, the FDA 510(k) submission specifies unique content and format provisions for a range of medical device types and classifications to demonstrate that the product is safe and effective. In Europe, the stricter Medical Device Regulation (MDR) went into effect this past May to replace the current Medical Device Directive. Companies have three years to ...
Source: MDDI - Category: Medical Devices Authors: Tags: Regulatory and Compliance Source Type: news