Current Regulatory Scenario for Medical Devices in the UK

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Current Regulatory Scenario for Medical Devices in the UK

The current Regulatory scenario for medical devices in the United Kingdom (UK) is governed by the Medical Devices Regulations 2002 (SI 2002 No. 618, as amended), also known as the UK MDR 2002. This framework was originally based on the European Union (EU) Directives, but following the UK’s exit from the EU, there have been changes to how medical devices are regulated in Great Britain (GB), comprising England, Wales, and Scotland.
Here are the key points with respect to the current Regulatory scenario for medical devices in the UK:

CE-marked Devices and the Great Britain Market Strategy

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CE-marked Devices and the Great Britain Market Strategy

Post the Brexit scenario, the Regulatory landscape for medical devices in the United Kingdom (UK) underwent a profound metamorphosis, significantly impacting manufacturers aiming to introduce their products. As the UK made an exit from the European Union (EU), there was a shift from Conformité Européenne (CE) marking to UK Conformity Assessed (UKCA) marking. However, presently, the Medicines and Healthcare products Regulatory Agency (MHRA) still allows the placing of CE-marked devices on the UK market.