Export attention! The UK no longer recognizes the CE certification mark and will enable independent certification
Recently, the official website of the British government officially announced that the transitional period for Brexit will end at the end of 2020 (from February 1, 2020 to December 31, 2020).
From January 1, 2021, the British Medicines and Healthcare Products Regulatory Agency (MHRA) will assume responsibility for the current UK medical device market through the EU system.
In other words, the United Kingdom will no longer use CE certification and open its own independent MHRA certification.
It is understood that the British medical device regulations will officially leave the European Union in January 2021. From January 1, 2021, the British Medicines and Healthcare Products Administration (MHRA) will assume responsibility for the British medical device market currently under the responsibility of the EU system. Responsibility.
Recently, the United Kingdom issued new regulations on medical device regulations and safety guidelines for medical device audit standards in the United Kingdom, Northern Ireland and the European Union (Northern Ireland will implement different rules from the United Kingdom). After a transition period, the UK will no longer recognize the CE mark. After this, the manufacturer must affix the UKCA (UK Conformity Assessment Mark) mark. It will replace the CE mark in the UK market.
The UKCA (United Kingdom Conformity Assessment) mark is a new British product mark that will be used for certain products, including medical devices, that will be placed on the UK market after the transition period.
The UKCA mark will not be recognized in the European Union, EEA or Northern Ireland markets, and products that currently require CE marking still require the CE mark sold in these markets. From January 1, 2021, manufacturers will be able to use the UKCA logo.
Starting from July 1, 2023, to put the device on the UK market, you need to meet the requirements for placing the UKCA mark on the device. This requirement does not apply to Northern Irish merchants.
CE certification will expire in 2023
From January 1, 2021, many changes will take place in the launch of medical devices in the UK. these are:
The CE mark will continue to be used and recognized until June 30, 2023
The certificate issued by the designated agency of the European Economic Area (EEA) will continue to be valid for the UK market until June 30, 2023
From January 1, 2021, manufacturers who wish to place devices on the UK market will have a new way to market and product marking.
From January 1, 2021, all medical devices and in vitro diagnostic medical devices (IVD) placed on the UK market will need to be registered in the MHRA. There will be a grace period for registration:
Type III and IIb implants and all active implantable medical devices are 4 months
8 months for other Class IIb and all Class IIa equipment
Class I equipment is 12 months
The above 12-month grace period does not apply to manufacturers of Class I equipment and general IVD that currently need to register with MHRA.
If you are a manufacturer outside the UK and want to put your equipment on the UK market, you need to establish a UK responsible person who is responsible for the product in the UK.