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.

Medical device industry is witnessing rapid Regulatory reforms, thanks to evolving technologies and scientific developments. In this rapid development scenario, to aid medical device manufacturers, notified bodies, and other stakeholders align with the sophistication and globalization, Regulatory bodies are parallelly revamping the compliance standards. Same is the case with EU MDR which will come into effect from May 26, 2021, with new regulations, to increase the safety, accountability, transparency and traceability of medical devices.