As a result of Brexit and the Northern Ireland Protocol, the product compliance regime applicable to manufactured products placed on the Northern Ireland market currently requires that EU law continues to apply to such products. Our earlier product compliance and liability article (here) briefly addresses the regulatory position applicable to Northern Ireland. The UK Government guidance (here) continues to set out the current regulatory position, including the use of the UKNI marking under certain circumstances.

Controversially, the proposed Northern Ireland Protocol Bill (here), which has already reached its second reading in the House of Lords, aims to introduce a dual-regulatory regime, which essentially gives Northern Ireland businesses the choice to comply with either Great Britain or EU product compliance regulations in respect of products being placed on the Northern Ireland market but which are not intended to be placed on the EU market.

It remains to be seen if the Bill will be passed into law in its current form, if at all, and how the practicalities of such a proposed regime will be implemented by way of further regulation. In this regard, the UK Foreign, Commonwealth & Development Office has recently published a policy paper (here) setting out its proposed “solution” to the Northern Ireland Protocol and how such a dual-regulatory regime might be realised, albeit in limited detail at this stage.

Given the potential implications of the dual-regulatory regime in the Northern Ireland market in a broad range of sectors, the Department of Health and Social Care is, in the context of health-related products including medical devices, seeking input from various stakeholders by way of a survey (here). Responses to such survey are required to be submitted by 2 August 2022.