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UK Regulator Publishes Response to Public Consultation on New IVD Regulations

NEW YORK – The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has published its response to a two-month-long consultation it held last year with the medtech community in the country regarding future domestic regulation of medical devices and in vitro diagnostics.

The response is part of an ongoing process by UK regulators to implement new regulations covering medical devices and IVDs following the UK's 2020 exit from the EU. Regulators are tasked not only with devising a new regulatory framework for the UK, but also aligning it with the island nation's closest market in Europe.

MHRA posted the 155-page document, "Government Response to Consultation on the Future Regulation of Medical Devices in the United Kingdom," on its website on June 26. The response includes proposed regulations of medical devices and IVDs, the feedback gathered from respondents during the consultation period, and the government's responses to that input.

Sajid Javid, secretary of state for health and social care, said in a statement included in the consultation response that the UK's decision to leave the EU presented the UK with a "great opportunity" to build its own regulatory regime. Javid also said that the COVID-19 pandemic had spurred "huge advances in the life sciences and diagnostics."

MHRA, which oversees the regulation of medical devices and IVDs in the UK, published a draft guidance on future regulations last year, and began a consultation with the medtech sector in September, which concluded in November. During the consultation period, it received 891 responses from individuals and organizations, including 200 medical device manufacturers, 56 healthcare institutions, 24 trade associations, and 172 small- and medium-sized enterprises.

Overall, MHRA said it received "strong support" from respondents for the proposals outlined in its draft regulation, which encompasses 15 technical chapters including device classification; registration procedures; rules governing approved bodies; regulation of IVDs and software used as a medical device; and post-market surveillance requirements.

In particular, respondents expressed a desire to align the new UK regulatory regime with the EU's new In Vitro Diagnostic Regulation, which began to apply last month. "A significant number of responses requested close alignment" with the IVDR, MHRA reported, "to avoid confusion and potentially duplicative or divergent requirements and to facilitate the ongoing supply of devices to the UK market." In light of this, MHRA said it intends to reflect the general safety and performance requirements of the IVDR in the UK regulations, tailored to the domestic context.

The UK will continue to transition to its new regulatory regime, MHRA reported, which means that manufacturers holding a CE-IVD mark are expected to obtain a UK Conformity Assessed mark from a government-designated approved body by July 2023.

In a separate statement, the British In Vitro Diagnostics Association, a trade organization that represents the UK IVD industry, called the publication of MHRA's response to the consultation a "huge step for regulation" in the UK, noting that the UK will be aligning with the EU regulatory route, with some UK-specific requirements.

BIVDA said that it is important that the UK ensure sufficient capacity of approved bodies to oversee the transition to the new regulatory regime, especially as a shortage in regulatory capacity has caused the EU to extend the transition periods for some classes of tests to the IVDR.

Ashleigh Batchen, BIVDA's regulatory affairs manager, in a statement called the new publication a "much-needed step in allowing industry and other stakeholders involved to understand what is required of them within the new regulation."

BIVDA said it will continue to work with stakeholders to support the transition to the new UK regulatory regime in order to "avoid disruptions in the supply of life-saving diagnostics."