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Medical Devices

Transition from Medical Device Directive to Medical Device Regulation

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Introduction ‘The Medical Device and In Vitro Medical Device Regulations represent the most significant change to European legislation for medical devices in over 20 years’ (Hoxey). As of the fifth of May 2017, new MDR and IVDR regulations have been approved and published by the European Commission. The new regulations will replace the directives; MDD, …

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EU Medical Device In Vitro Diagnostic Medical Device Regulations November 2017

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The EU’s Regulation (EU) 2017/745 (Medical Device Regulation (MDR)) came into force on 25 May 2017 and will replace the EU’s current Medical Device Directive (93/42/EEC) and the Directive on active implantable medical devices (90/385/EEC). Manufacturers of currently-approved medical devices will have a transition time of three years until May 26th 2020 to meet the …

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ISO 13485: Medical Devices – Quality Management Systems

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ISO 13485: Medical devices – quality management systems was published in March 2016. This third edition cancels and replaces the second edition (ISO 13485:2003), which has been technically revised. Rather controversially, ISO 13485:2016 has not been revised in line with the high level structure, HLS, adopted by ISO 9001:2015, ISO 14001:2015 and 30 other management …

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