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Full Description
New and emerging technologies as well as various well-known incidents within the medical device industry have challenged the current framework, highlighted gaps and pointed to a certain scarcity of skills and expertise. For this reason, there was increasing need to update the European Medical Device Directives. This has since led to the development and release of the Medical Device Regulation (MDR 2017/745) which has now put stricter regulatory controls on the entire product life cycle. Both the EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) contain a complete section on economic operators for medical devices. Although the manufacturer is ultimately responsible for ensuring their medical device is compliant with the relevant legislation, the various defined economic operators within the Regulation, now have a part to play in ensuring the safety and performance of the device throughout the supply chain. This new policy of sharing compliance is an important component of the MDR2017/745 with each economic operator serving as a control on the other, causing each device to receive a number of checks throughout the process before it is brought to market. In addition to this, it also allows for any compliance issues emerging from any one of the economic operators to have a direct legal implication on the other. Changes brought about by the MDR2017/745 in Europe require not only manufacturers but all defined economic operators to take a proactive, multilevel and multidisciplinary approach when it comes to ensuring safe and effective devices are placed on the market. This volume looks at each Economic Operator in greater details with their relevant responsibilities.
Contents
Chapter 1 The History of Medical Device Regulations
Chapter 2 The CE Mark Process
Chapter 3 Classification of a Medical Device
Chapter 4 Quality Management System
Chapter 5 Technical File/STED
Chapter 6 Appointing an Authorized Representative
Chapter 7 Declaration of Conformity
Chapter 8 The Medical Device Directive 93/42/EEC
Chapter 9 The Medical Device Regulation 2017/745
Chapter 10 Economic Operators
Chapter 11 Designating a Person Responsible for Regulatory Compliance
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