Medical Devices Regulation (EU) 2017/745
Notified Body 2460. Certification verifies that you meet all regulations required to get EU market access.
On 5 May 2017, two new Regulations on medical devices were published, and they entered into force on 25 May 2017. The Medical Devices Regulation (MDR) date of application is 26 May 2021 meaning compliance is mandatory to be able to place Medical Devices on the European market from this date, unless the transition arrangements allows the continued placing of devices on the market. In vitro Diagnostic Medical Devices Regulation (IVDR) applies from 26 May 2022.
Products intended for the UK market must be compliant with the new product marking UKCA launched by the UK government on 1 January 2021. For medical devices, the UKCA transition period is currently set to 30 June 2023.
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