Tips for Putting Medical Devices to the Market of Great Britain
In Great Britain, classification of medical devices is similar to the EU legislation and can be divided into 3 main types:
general medical devices
active implantable medical devices
in vitro diagnostic medical devices (IVDs)
However, the medical devices in Great Britain are subject to the national Medical Devices Regulations 2002 (UK MDR 2002). Each type of the device is subject to relevant part of the UK MDR 2002, namely:
general medical devices are regulated by Part II of the UK MDR 2002
active implantable medical devices are regulated by Part III of the UK MDR 2002
in vitro diagnostic medical devices are regulated by Part IV of the UK MDR 2002
Here we will talk about general medical devices. They can be classified on the level of risk to human health and life as follow:
Class I - generally regarded as low risk
Class IIa - generally regarded as medium risk
Class IIb - generally regarded as medium risk
Class III - generally regarded as high risk
The UK medical device market is regulated by the Medicines and Healthcare products Regulatory Agency (MHRA). Starting from January 1, 2021, all medical devices that are intended to be sold on the Great Britain market need to be registered with the MHRA. They gave a grace period for registering:
Class III and Class IIb implantables, and all active implantable medical devices must be registered from May 1, 2021
Other Class IIb and all Class IIa devices must be registered from September 1, 2021
Class I devices, custom-made devices must be registered from January 1, 2022
The conformity assessment procedure depends on the class of the device. Anyway, you need to write a declaration of conformity against the UK MDR 2002 requirements and involve a UK Approved body. Only after checking the technical documentation as well as clinical and scientific data, manufacturing processes and the quality management system, the Body issues the UKCA Certificate and grants the right to affix the UKCA conformity mark to the device. Apart from the UKCA mark, it is necessary to put an identification number of an Approved Body if it has been involved in the conformity assessment procedure.
Please, note that it is possible to use any international standard that has been designated to the UK MDR 2002 to show the compliance with the Regulation.
So, currently the UK legislation is based on the relevant EU Directives. That is why CE marked devices with a valid declaration of conformity or certificate are considered to meet the UKCA mark requirements. The CE marked devices will be recognized in Great Britain until 30 June 2023.
In case the manufacturer is located outside the UK, he must have a local authorized representative in the UK who takes responsibility for the product in the Great Britain.
When the device has a valid CE mark, there is no need to apply for the UKCA marking up to July 1, 2023. After this date, the UKCA mark will be required. In any case, both CE and UKCA marks can be presented on the device not only prior but also after July 2023.
The information has been prepared by the GMA Consult Group team. GMA Consult Group provides a full cycle of international type approval and global market access services for IT, Telecom, and industrial electrical products in all countries throughout the world. With proven expertise in worldwide regulations, compliance, certification, and conformity assessment, GMA Consult Group can help your company speed up the access to any market with almost zero efforts from your side.
Need your own guide to the world of certification and approvals? Don't hesitate to contact us via firstname.lastname@example.org.