The MHRA released a statement today regarding the EU Commission’s intent to extend the MDR transition period, available: HERE

The most obvious impact is related to Northern Ireland.

The UK is made up of the following four countries: England, Scotland, Wales (“Great Britain”) and Northern Ireland.

Great Britain is expected to eventually require UKCA marking. However, Northern Ireland currently requires, and will continue to require, European CE Marking. Therefore, the MHRA confirms that once the extension of the MDR transition period is granted, it will automatically apply in Northern Ireland.

The MHRA has not yet formally decided if/how the MDR extension will impact Great Britain. Instead, the MHRA advised they will carefully consider the implications.

Currently, the UK legislation states that manufacturers must UKCA mark by 30 June 2023 in order to continue marketing in Great Britain. However, the MHRA has also confirmed that they will postpone the deadline to July 2024, and further, that they will extend the timeframe in which they will allow CE Marked devices onto the market.

For more information on the EU Commission’s intent to extend the MDR transition period, please read: EU Parliament votes “yes” to the MDR Postponement

For more information on the UK MHRA’s intent to extend the CE Marking acceptance period, please read: UKCA Marking Postponed & CE Marking Transition Period Extended