Single-use medical devices: implications and consequences of re-use
This guidance covers:legal implicationsnegligenceregulatory requirementssafety issues
Warfarin and other anticoagulants – monitoring of patients during the COVID-19 pandemic
Supratherapeutic anticoagulation observed during the pandemicThe MHRA has been contacted by King’s College Hospital in London regarding their concerns over an apparent increase in the number of patients taking warfarin…
Guidance for Manufacturers Specials licence holders on ‘packing down’ medicines during the coronavirus (COVID-19) outbreak
The MHRA has received several enquiries about whether organisations can ‘pack down’ large packs of licenced medicinal products into smaller quantities for retail sale.Any packs prepared under this guidance cannot…
Virtual manufacturing of medical devices
All virtual manufacturers must now hold the full technical documentation for any product they place on the market under their name.
Centrally Authorised Products (CAPs) Bridging Mechanism
This guidance applies until such time as the Windsor Framework takes effect on 1 January 2025. Under the Windsor Framework, rather than novel medicines for use in Northern Ireland requiring…
