What you need to do to place a medical device on the Great Britain, Northern Ireland and European Union (EU) markets. This is an extract of the information published by the MHRA on their website.
Summary of key requirements for placing a device on the Great Britain market:
Since 1 January 2021, there have been a number of changes, introduced through secondary legislation, to how medical devices are placed on the market in Great Britain (England, Wales and Scotland). These are:
a new route to market and product marking (the UKCA marking) is available for manufacturers wishing to place medical devices on the Great Britain market
all medical devices, including in vitro diagnostic medical devices (IVDs), custom-made devices and systems or procedure packs, need to be registered with the MHRA before they are placed on the Great Britain market
if you are a medical device manufacturer based outside the UK and wish to place a device on the Great Britain market, you need to appoint a single UK Responsible Person for all of your devices, who will act on your behalf to carry out specified tasks, such as registration. Further detail on the UK Responsible Person
Currently, CE marked medical devices with a valid CE marking can be placed on the Great Britain market until 30 June 2023. A valid CE marking is a CE marking that enables the medical device to be placed on the EU market. However, subject to Parliamentary approval, we intend to introduce measures before 30 June 2023 which will provide that CE marked medical devices may be placed on the Great Britain market to the following timelines:
general medical devices compliant with the EU medical devices directive (EU MDD) or EU active implantable medical devices directive (AIMDD) with a valid declaration and CE marking can be placed on the Great Britain market up until the sooner of expiry of certificate or 30 June 2028
in vitro diagnostic medical devices (IVDs) compliant with the EU in vitro diagnostic medical devices directive (IVDD) can be placed on the Great Britain market up until the sooner of expiry of certificate or 30 June 2030, and
general medical devices including custom-made devices, compliant with the EU medical devices regulation (EU MDR) and IVDs compliant with the EU in vitro diagnostic medical devices regulation (EU IVDR) can be placed on the Great Britain market up until 30 June 2030.
This would enable certain CE marked medical devices to continue to be placed on the Great Britain market for longer.
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