OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

The technical documentation and, if applicable, the summary thereof to be drawn up by the manufacturer shall be presented in a clear, organized, readily searchable and unambiguous manner and shall include in particular the elements listed in this Annex. Related act, regulation, directive, standards and guidance, implementation of requirements, maintaining continuously documents including updating and added activities, for technical documentation and quality management system and so on.

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Medical practice is increasingly using MEDICAL DEVICES for observation and treatment of PATIENTS. USE ERRORS caused by inadequate MEDICAL DEVICE USABILITY have become an increasing cause for concern. Many of the MEDICAL DEVICES developed without applying a USABILITY ENGINEERING (HUMAN FACTORS ENGINEERING) PROCESS are non-intuitive, difficult to learn and difficult to use. As healthcare evolves, less skilled USERS including PATIENTS themselves are now using MEDICAL DEVICES and MEDICAL DEVICES are becoming more complicated. The design of the USER INTERFACE to achieve adequate USABILITY requires a different PROCESS and skill set than that of the technical implementation of the USER INTERFACE.

The post-market surveillance system shall be suited to actively and systematically gathering, recording and analyzing relevant data on the quality, performance and safety of a device throughout its entire lifetime, and to drawing the necessary conclusions and to determining, implementing and monitoring any preventive and corrective actions.

International Standard IEC 62304 has been prepared by a joint working group of subcommittee 62A: Common aspects of electrical equipment used in medical practice, of IEC technical committee 62: Electrical equipment in medical practice and ISO Technical Committee 210, Quality management and corresponding general aspects for MEDICAL DEVICES. Table C.5 was prepared by ISO/IEC JTC 1/SC 7, Software and system engineering.

Confirmation of conformity with relevant general safety and performance requirements set out in Annex I under the normal conditions of the intended use of the device, and the evaluation of the undesirable side-effects and of the acceptability of the benefit-risk- ratio referred to in Sections 1 and 8 of Annex I, shall be based on clinical data providing sufficient clinical evidence, including where applicable relevant data as referred to in Annex III.

Manufacturers shall establish, implement, document and maintain a risk management system. Risk management shall be understood as a continuous iterative process throughout the entire lifecycle of a device, requiring regular systematic updating.

The risks associated with the possible negative interaction between software and the IT environment within which it operates and interacts. Devices that are intended to be operated together with other devices or products shall be designed and manufactured in such a way that the interoperability and compatibility are reliable and safe. Devices shall be designed and manufactured in such a way as to protect, as far as possible, against unauthorized access that could hamper the device from functioning as intended.

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