The new Medical Device Regulation (MDR) places a greater emphasis on clinical evaluation and clinical investigations as part of the conformity assessment process. Current CE marked products will not be "grandfathered" and will need to meet the requirements of the new regulation. Thus, many companies will face a significant challenge to provide the required clinical safety and performance information for previously CE marked devices. Companies will also have the added challenge to update their quality management system to conform with the new standards and regulations. In order to address these industry needs, A.P. Lyon developed a series of clinical evaluation and quality system products designed for medical device manufacturers to simplify the transition.
A.P. Lyon released multiple procedures that comply with the MDR, ISO 13485:2016 and the FDA QSR to ensure manufactures comply with the new requirements. The company also created a comprehensive ISO 13485:2016 quality management system that governs multiple aspects of medical device design, development and pre- and post-commercialization activities. The A.P. Lyon quality system products seek to harmonize the global medical device requirements in an intuitive, user friendly manner that simplifies quality system implementation/modification and in a manner that promotes its continued use.
Incorporating risk management throughout all aspects of medical device manufacture and commercialization is a common theme in the recent changes to various standards and regulations. The risk management system that A.P. Lyon has incorporated into their system products is aligned with and reflected in the clinical evaluation process for a medical device, including the clinical risks to be addressed as part of clinical investigations and clinical evaluation and post-market clinical follow up. The risk management procedures instruction on device characterization, risk assessment, risk-benefit analysis and all risk related activities.
New Unique Device Identification (UDI) requirements have been incorporated into both U.S. and European regulations. In order to help companies address the new global requirements associated with the traceability of devices by means of a UDI system, a procedure based on international guidance was created to help manufacturers adhere to the new requirements and provide instruction on both formatting UDI's and for data entry into FDA GUDID and EUDAMED systems.
A.P. Lyon's quality system procedures aim to help manufacturers continue to meet their previous critical obligations that were made part of the MDD and FDA CFR's, such as clinical evaluation reports (CER), medical device reports or vigilance reporting and the post-market surveillance and the risk management process.