ARTICLE SUMMARY:
In this week’s Pathways Picks: UK floats legislation that could lead to direct MHRA device reviews, rather than third-party assessments; FDA signs a memorandum of understanding with the Securities and Exchange Commission; China issues 100-plus draft device-specific guidance documents in one day; and more global medtech policy updates.
UK Eyes Centralized Licensing
The UK Medicines and Healthcare products Regulatory Agency is seeking a “legal foundation” to pursue a new device regime in the future that would “require a license issued by the MHRA, rather than relying on third-party conformity assessments.” The UK government sent a legislative amendment for consideration by the Parliament this week to provide MHRA the “enabling powers” to pursue a more centralized review mechanism, akin to the US FDA process, instead of current reliance on UK Approved Bodies. To be clear, the legislation would not actually establish the new regime, just give MHRA runway to develop it via “future policy work, public consultation, impact assessment and parliamentary scrutiny.”
The legislative amendment was sent to Parliament along with other reform proposals that would allow the government to update device and drug regulations more quickly in response to technological changes and to give MHRA clearer powers to share information about drugs and devices with other UK agencies and global partners to support public health, safety, access to innovation, and effective regulation.
These items were tabled as the UK is moving toward formal adoption of broadscale reforms to device regulations that were developed in the wake of the country’s exit from the EU.
