EU MDR

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Medical devices sold in Great Britain to require a new UK product safety marking
By  Tammy Lovell 01:27 pm September 7, 2020
The UK government has released a proposed regime on the regulation of medical devices in Great Britain, Northern Ireland and the European Union post Brexit. Under the guidance, the Medicines and Healthcare products Regulatory Agency (MHRA) will continue to recognise CE marks and certificates issued by European Economic Area-based Notified Bodies until 30 June 2023. From 1 July, companies will...
Medical device manufacturers face challenges preparing for ‘stringent’ new EU Regulation
By  Tammy Lovell 05:15 am February 12, 2020
The countdown is on for medical device manufacturers to prepare for the EU Regulation on Medical Devices (MDR), which will fully apply in member states from May this year. But in a recently published paper, trade association MedTech Europe raised concerns that the new regulatory system is not ready to support the transition of technology from the old regime. The new EU MDR came into force on May...

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