UK regulators have laid out a comprehensive reform plan for regulating devices and IVDs in the UK. Excerpted from Pathways' Picks September 22.
The Medicines and Healthcare products Regulation Agency (MHRA) consultation, issued September 17, is a key step in the preparation of UK-specific requirements to support the post-Brexit “UK CA mark” for devices by the July 2023 transition date set by MHRA.
The proposal includes many of the elements previewed by MHRA officials and industry stakeholders, such as frameworks for risk classification, clinical investigations, “approved bodies,” and establishing a UK-specific registration and database requirement. It also describes more specific regulatory structures for product categories including implantable devices, single-use devices, IVDs, and software as a medical device (SaMD). In parallel to the broader consultation, MHRA issued a guidance document homing in on its plans for standing up a targeted regulatory approach for SaMD. The agency also proposed a special development pathway for “innovative medtech” that would include additional research and data-gathering support from MHRA, the prospect of early, condition approval, and involvement by the UK National Institute of Health and Care Excellence (NICE) technology assessment body. Overall, the plan makes some efforts to align with the new EU MDR/IVD system, but is even more focused on establishing global harmonization a broader level.
Notably, the consultation is based on the updated UK Medicines and Medical Devices Act approved by Parliament earlier this year. That legislation requires MHRA’s new regulations to ensure 1) safety of medical devices, 2) “availability” of devices, and 3) “the likelihood of the United Kingdom being seen as a favourable place in which to— i) carry out research relating to medical devices, ii) develop medical devices, or iii) manufacture or supply medical devices.” That last factor linked to market favorability is particularly unusual for medical product legislation and has made industry optimistic about the process. Stakeholders have until November 25 to provide written feedback on the consultation, and UK-based industry is gearing up. “The starting pistol has fired. This is our opportunity to lead on a key issue that will influence our industry for years to come across the whole spectrum of products including devices, digital health and diagnostics,” ABHI, the UK industry trade group, wrote in a memo to members.
Excerpted from “Pathways’ Picks September 22: UK Looks Ahead, China Keeps Busy, and More to Watch,” Market Pathways, September 22, 2021.
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