For medical devices, the UK's Medicines and Healthcare products Regulatory Agency (MHRA) provides guidance on how medical devices are now being regulated. As of 1 January 2021, medical devices being placed on the market in the UK must follow new legislation: the Medical Devices Regulations 2002 (SI 2002 No 618, as amended), known as UK MDR. The UK MDR incorporates the requirements, according to EU legislation, for: 1.Active implantable medical devices - Directive 90/385/EEC (AIMDD) 2.General medical devices - Directive 93/42/EEC (MDD) 3.In vitro diagnostic medical devices - Directive 98/79/EC (IVDD) Although the UKCA mark may be required to place medical devices on the market in GB, from 1 January 2021, CE marked devices are also permitted. However, from 1 July 2023, it will be mandatory for every medical device to display the UKCA marking.
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