On September 18, Robert Reid, Ph.D. Deputy Director, Innovative Devices at the Medicines and Healthcare products Regulatory Agency (MHRA), updated the RAPS audience on the current status of the UK legislation. To our knowledge, this is one of the most recent updates from the MHRA.
The first half of 2024
In January 2024, the MHRA shared a roadmap for 2024-2025. The roadmap proposed regulatory reforms to the UK MDR 2002 based on previous reports and consultations. Three core legislations (statutory instruments (SI)) are envisioned: post-market surveillance (PMS), pre-market/core legislation, and future enhancements. Notification of the draft PMS SI was published on the WHO website at the end of July 2023, and it was expected to enter into force in June 2024, which has not yet happened.
Around the same time as the election of the new UK government, in May 2024, Dr. Reid assumed his new position at the MHRA. Under the new labor government, Baroness Merron was appointed as the Parliamentary Under-Secretary of State at the Department of Health and Social Care in July, all of which have impacted the legislative process.
UK Medical Device Regulator MHRA Announces Legislative Updates | Emergo by UL
UK Medical Device Regulator MHRA Announces Legislative Updates
MHRA, the UK medical device regulator, gave a progress report on the agency's work toward completing its roadmap of medical device legislation.
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