How have the medical device regulations changed this year?

20th January, 2021

By Alice Green, Innovation Manager, Health Enterprise East

What is the new CA mark?

The UKCA (UK Conformity Assessed) mark will be a new UK specific mark that will be used for goods being placed on the market in Great Britain (England, Wales and Scotland). It will cover the majority of products that currently require a CE mark to be sold in the EU.

What does this mean in practice?

From 1 January 2021 the requirements, the conformity assessment processes and standards remain largely unchanged for those placing products on market as a new transition period begins. Although the new UKCA marking can be used from 1 January 2021, businesses have time to adjust to the new requirements and will still be able to use their exiting CE marking until 1 January 2022 in most cases.

Although some details are still to be ironed out there are some key dates to note:

26th May 2021, EU MDR date of application

26th May 2022, EU IVDR date of application

30th June 2023, CE marks no longer recognised in UK

26th May 2024, MDD and IVDD certificates invalid

There are currently no plans for the UK to adopt MDR or IVDR (the EU regulations that are transitioning into force in the EU) into UK Law. This means that the UK will continue to use the existing EU directives (MDD and IVDD) until a UK specific system finalised. There are currently no provisions in place for the UK CA Mark to be recognised in EU. However, the UK will continue recognise CE Marks, that are issued under either the Directives or the Regulations, until 30th June 2023.

For more information and help with understanding the new regulatory requirements in the UK and EU, visit our MedTech Regulation page.

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