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EU Medical Devices Regulations

The government state that the MDR will come in to effect in May 2020, and the IVDR in May 2022, however the United States has called upon the EU to delay the implementation of Medical Device Regulations and In Vitro Diagnostic Regulations by 3 years. Read more

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Sumitomo (SHI) Demag, has pioneered a fully automated in mould decorating production cell. This cell can be used to issue medical devices with unique device identifications ahead of the enforcement of the EU medical device regulations. Read more

North America

Mark Cusworth examines EU Medical Device Regulation and its implications on labeling – and looks ahead to a Christmas future that could become a nightmare unless companies act now. Read more

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The UK Medicines & Healthcare products Regulatory Agency has issued new guidance for medical device makers when taking human factors into account. Read more

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