The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published its responses to the consultation on Medical Device Regulations: Routes to market and in vitro diagnostic devices carried out last year....more
8/6/2025
/ Diagnostic Tests ,
EU ,
Health Care Providers ,
International Harmonization ,
Life Sciences ,
Manufacturers ,
Medical Devices ,
Medicines and Healthcare Products Regulatory Agency (MHRA) ,
New Regulations ,
Regulatory Reform ,
Regulatory Requirements ,
Risk Management ,
UK
A draft Statutory Instrument was laid before UK Parliament on 22 October 2024 which, once passed, will introduce new post-market surveillance (PMS) requirements for medical devices and in vitro medical devices (IVDs) in the...more
The UK's Medicines and Healthcare products Regulatory Agency ("MHRA") has announced first-of-its-kind legislation to better facilitate the manufacture and delivery to patients of medicines that are manufactured at or near the...more