Given all the recent attention that has rightly been placed on the upcoming changes to medicinal products for the UK market, as a result of the implementation of parts of the Windsor Framework, it would be easy to assume that similar changes or at least thought processes would apply to other products.
However, it is important to note that Medical Devices will not go through a similar evolution, whereby Northern Ireland is integrated into a single UK market for medicines. Under the Windsor Framework, meaning that the rules for placing medical devices onto the Northern Ireland Market differ from those applicable to Great Britain. Medical devices in Northern Ireland must continue to be ‘approved’ under EU legislation and carry a valid CE mark. There are many complexities to the situation in Northern Ireland and certainly beyond the scope of this blog but some of the key issues are:-
- Medical devices and IVDs sold in Northern Ireland must fully comply with EU Medical Device Regulation (2017/745) (MDR) and the In Vitro Diagnostic Medical Device Regulation (2017/746) (IVDR).
- There are some potentially significant differences between the EU MDR/IVDR and current UK legislation including rules for classification. Manufacturers, and Importers & distributors in Northern Ireland, must ensure they and the products that they offer, fully comply with the EU legislation. This requirement has operational implications as well as those relating to the product itself.
- The MHRA is the Competent Authority for Medical devices and IVDs in Northern Ireland, though products will usually need to undergo conformity assessment, where applicable, by an EU based Notified Boby.
- Devices carrying only the UKCA mark cannot be sold in Northern Ireland.
- It will still be possible to use a UK-based Notified Body for conformity assessment for products intended for the Northern Ireland market, with the products being required to carry a combined CE and UK(NI) making. These products can be placed on the whole UK market but will not be acceptable in the EU market.
So if you are a manufacturer intending to have your product available in Northern Ireland or are a UK distributor supplying into Northern Ireland, you need to carefully check you compliance with these requirements. Further information can be found in the Guidance published by the MHRA under the title – Regulation of devices in Northern Ireland.