In recent times the need for improving regulatory controls and finding ways to improve the quality and access to safe medical devices has increased. The Medical Devices Directive 93/42/EEC was enforced to provide a harmonised regulatory environment for all medical devices sold within the European Union however new and emerging technologies as well as various well-known incidents within the medical device industry have challenged the current framework and highlighted gaps and a scarcity of skills and expertise. For this ...
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In recent times the need for improving regulatory controls and finding ways to improve the quality and access to safe medical devices has increased. The Medical Devices Directive 93/42/EEC was enforced to provide a harmonised regulatory environment for all medical devices sold within the European Union however new and emerging technologies as well as various well-known incidents within the medical device industry have challenged the current framework and highlighted gaps and a scarcity of skills and expertise. For this reason, there has been an increasing need to update the MDD which led to the development and release of the Medical Device Regulation (EU MDR 2017/745). This has since marked the start of a three-year transition period for manufacturers, suppliers, Notified Bodies, and National Competent Authorities. While compliance to the new regulation was set to take effect in May of 2020, it has now been postponed by a year due to the recent coronavirus pandemic. This has essentially given manufacturers more time to assess their overall readiness and reprioritize the time-consuming areas of the transition. This volume aims to provide an easy-to-understand guide for beginners to the medical device regulations in Europe and looks specifically at the changes between the current Medical Device Directive 93/42/EEC and forthcoming Medical Devices Regulation (EU MDR 2017/745) with regards to classification, conformity assessments and assessing general safety and performance requirements.
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