In his negotiations with the EU, Boris Johnson prioritised the UK’s ability to set its own rules and regulations (at least in respect of Great Britain). Yet more than five years after the UK voted to leave the EU, Johnson’s government is still struggling to articulate its vision for what it wants the UK to do differently from the EU and, more importantly, why. Medical device regulation provides an instructive example of both the opportunities now open to the UK, but also the constraints it will find itself under.
Medical devices are technologies that help diagnose or treat patients, or prevent illness without the use of drugs. They include everything from MRI scanners, hip implants and scalpel blades to smartphone apps that treat depression. The EU is currently struggling to implement a wide-ranging change in how medical devices are regulated – from the 1993 Medical Device Directive (MDD) to the 2017 Medical Device Regulation (MDR). Phased introduction of the MDR was due to be completed by May 2020, but was extended until this year due to COVID-19 pressures. This new regulatory framework is designed to ensure more thorough testing of devices before they can be used on patients, and more rigorous monitoring of performance of devices once on the market. The MDR’s implementation, however, has not gone smoothly.insight_med_devices_SL_DH_5.8.21
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