ARTICLE SUMMARY:
In this week’s roundup: The UK government issued its official response on the next steps toward a regulatory framework for devices and IVDs, signaling plans to extend transition deadlines but otherwise, largely, sticking to its plans; China update on a provincial early-access program for devices and drugs and national guidance documents; UDI news from Saudi Arabia and Australia; and more from Canada, Europe, and the US.
[Editor’s note: We will not publish Pathways’ Picks next week, but will return July 13. Go to Market Pathways’ home page for more medtech policy features, news, and analysis.]
Top Pick: UK Device Framework
Transitions extended, plans set in place:
Transitions extended. UK is moving ahead to forge its own post-Brexit device and IVD regulatory framework but it is relenting to calls for longer times for device and IVD makers to transition to the new rules. The Medicines and Healthcare products Regulatory Agency (MHRA) laid out the path forward June 26 in its official response to stakeholder feedback on MHRA’s 2021 consultation about the future of UK device/IVD regulations. MHRA has designated July 2023 as the start-date for its new regime and it is sticking with that, but the agency now says products that are already certified under the EU Medical Device Regulation, the IVD Regulation, or the legacy IVD Directive can stay on the UK market for up to an additional five years after the UK law takes effect, as long as they don’t undergo significant changes and they comply with updated postmarket requirements. Devices certified under the legacy medical device Directives (MDD or AIMDD) will have three years. And notably, products will not need to be registered with the MHRA to stay on the market after July 2023.
Harmonization beyond the EU. The extended timelines respond to concerns from industry about the challenge of making the UK transition at the same time the MDR and IVDR impacts are just beginning to be felt. MHRA’s 155-page response document outlines a plan that attempts to align its oversight system closely to newly implemented EU systems, but not exactly. MHRA wants to embed broader global harmonization into its system, which means it favors procedures set out by the International Medical Device Regulators Forum (IMDRF) in some areas, including, for instance, for its planned classification schemes for IVDs and “software as a medical device.” MHRA also declined to incorporate certain clinical investigations exemptions for implants that are included in the EU MDR. The UK agency also plans to move ahead with bespoke streamlined procedures for innovative devices and, in particular, digital health products, including the potential for conditional authorization and predetermined change control plans. (Also see, “Talks Ramp Up On Future UK Regulations,” Market Pathways, March 16, 2021.)
