1. UK’s medical device regulations after the transition period
At present, it is certain that within a period of time after January 1, 2021, the UK will adopt the MDD, IVDD and AIMDD directive systems, which will exist in the form of the UK MDR 2002 domestic laws.
2. UK’s new medical device regulatory system
The MMD Bill of the UK will introduce the secondary legislation to establish a new independent regulatory framework for the UK, which will be used to manage the safety and effectiveness of the medical device products marketed in the UK.
3. The MDR and IVDR will not be applicable in the GB regions
All the UK customers in the European market do not need to consider the requirements of the MDR and IVDR regulations. This is because the UK will not use the MDR and IVDR requirements to control the medical devices and IVDs of the importers.
4. Northern Ireland
The medical device regulatory system of Northern Ireland continues following the requirements of the EU, so it shall comply with the MDR and IVDR requirements of the EU. In addition, attention shall be paid to the compliance with the requirements for the MHRA registration in the UK.