Welcome to our websites!

Attention of medical and manufacturing enterprises!Independent certification system launched in the UK!No longer recognizes the CE mark

The UK government has officially announced on its website that the transition period for the UK to leave the European Union will end at the end of 2020 (from February 1 to December 31).

From 1 January 2021, the Medicines and Healthcare Products Regulatory Agency (MHRA) will assume responsibility for the UK medical device market currently conducted through the EU system.In other words, the UK will no longer use CE certification, but will start its own independent MHRA certification.

88

It is understood that the UK’s medical device regulations will formally leave the EU in January 2021. From January 1, 2021, the UK’s Medicines and Healthcare Products Authority (MHRA) will assume responsibility for the UK’s medical device market, which is currently under the EU system.

Recently, the UK issued medical device regulations and safety guidelines to set new standards for the review of medical devices in the UK, Northern Ireland and the EU (Northern Ireland will implement different rules from the UK).

After a transitional period, the UK will no longer recognise the CE mark.After this, the manufacturer must bear the UK UKCA (UK Compliance Assessment Mark) logo.It will replace the CE mark in the UK market.


Post time: Oct-30-2020