News / Blogs
Understanding UKCA marking and labelling requirements in Northern Ireland
The MHRA announced a one year delay for UKCA Marking and confirmed a 3 to 5 year transition period for CE Marked devices this week.
Understanding UKCA marking and labelling requirements for Great Britain
Shiro Business Solutions offers information on the UKCA marking required for medical devices sold on the market in Great Britain (GB).
Deadline to appoint a CH-REP for Class 1 & System/Procedure packs is approaching
The deadline for appointing a Swiss Authorised Representative (CH-REP) for Class 1 Devices, and System/Procedure Packs is fast approaching.
Medical Device Regulations in the UK: An Overview
The Medicines & Healthcare products Regulatory Agency (MHRA) has been responsible for medical device and pharmaceutical regulations in the United Kingdom since 2003
What is the UK Conformity Assessed Mark (UKCA)?
The United Kingdom Conformity Assessed (UKCA) mark is replacing the CE mark in Great Britain, as the United Kingdom left the EU single market on 31 December 2020.