The UK left the European Union on 31 January 2020. This meant that the UK would no longer follow EU legislation. However, it was agreed under the Northern Ireland Protocol that Northern Ireland would continue to follow the EU system, including EU legislation.
As a result, this meant that there are key differences between Northern Ireland and Great Britain requirements, including the need for CE marking in Northern Ireland. Medical devices and IVDs in Great Britain can utilise the UKCA mark on a voluntary basis until 30 June 2023, after which date the UKCA mark becomes mandatory. However, this marking will not be accepted on the Northern Ireland market unless the product also bears the CE marking.
This has created issues with border control between Great Britain and Northern Ireland, and generally is creating a difficult time for manufacturers to understand their requirements for both markets, including trade between both. There have been reports of supply shortages, but it is currently unclear if this has affected the medical device space.
Earlier this week, the UK Government announced that they will be reviewing the Northern Ireland Protocol to try and fix some of these issues. A draft of the legislation is expected in the ‘coming weeks’, which will then go through the legal processes as needed. This typically can take up to a year for implementation. As we don’t yet know what will be included in this draft, it is difficult to understand how this could affect IVD requirements.
It is unclear on how Europe and Northern Ireland are reacting to this anticipated change, but it’s expected that it may not be a completely smooth ride to amend the agreed upon legislation.