Zuhal Reed, Esq. | Risk Management Senior Staff Attorney | Medmarc
Brexit has given regulatory bodies in the United Kingdom (UK), such as the Medicines and Healthcare products Regulatory Agency (MHRA), great freedom. They are using that freedom to pave the way for bold new regulations. To bring this vision to life, the MHRA organized a ten-week consultation that reached its conclusion on November 25, 2021. The consultation focused on 15 areas, including classification of medical devices, registration, unique device identifiers, conformity assessment, clinical studies, in-vitro diagnostic devices (IVDs), software, and new routes to market. This consultation centered on the direction the MHRA will be moving in with regards to future regulation of medical devices. In particular, there was a unique focus on IVDs. The consultation explicitly laid out the following goals: create new pathways for approval, increase regulation of AI/ML-based SaMD, reinvigorate the regulation of IVDs, and encourage remanufacturing of medical devices to support increased sustainability.
This new framework diverges from the EU regulatory framework in some respects. Further, the consultation will result in guidance documents being released by the MHRA to provide support for medical device manufacturers and distributors. Some marked divergences noted during the consultation that do not appear in the current EU regulatory framework include: an emphasis on understanding the environmental and public health impact of a medical device, an understanding of supply chain waste management, new and faster methods of approval for medical devices intended to treat rare diseases, and the need for informing the MHRA expeditiously of any issues that may interrupt supply or cause a shortage. This consultation is noteworthy for medical device manufacturers and distributers as well as those currently running clinical trials with the hopes of manufacturing or distributing in the UK. If you have a manufacturing facility in the UK, if you distribute in the UK, or if you hope to distribute globally, this consultation will give you an idea of the guidance documents that will regulate your devices starting in 2023. Additionally, if you have been following EU regulations while distributing or manufacturing medical devices in the UK, these new changes will alter your business model and, in some cases, will create more stringent requirements.
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