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September 2017

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Products Streamline Compliance with New MDR

The new European Medical Device Regulation (MDR) EU 2017/745 lays down rules concerning the placing on the market of medical devices for human use. As part of a global harmonization effort, many aspects of the new MDR is aligned with requirements noted in the U.S. FDA CFRs, as well as the recent release of ISO 13485:2016, an international standard governing medical device quality man agement systems.

The 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 manufacturers comply with the new requirements. A.P. Lyon 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 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 its 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 content of A.P. Lyon risk management procedures provides clear and precise instruction on device characterization, risk assessment, risk-benefit analysis and all risk related activities," said a company spokesperson.

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 comprehensive procedure based on international guidance was created and should help manufacturers adhere to the new requirements and provide instruction on both formatting UDIs and for data entry into FDA GUDID and EUDAMED systems.

A.P. Lyon's quality system procedures help manufacturers continue to meet their previous critical obligations that were made part of the MDD and FDA CFRs, such as clinical evaluation reports (CER), medical device reports or vigilance reporting, post-market surveillance and risk management process, ensuring these activities are properly carried out within the manufacturer's organization.

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