On 29 April 2021, the MHRA updated its guidance on how the EU MDR and IVDR (the EU Regulations) will apply in Northern Ireland.
Under the terms of the Northern Ireland Protocol, different rules apply in Northern Ireland and the rest of the UK when placing medical devices on the market. The EU Regulations will apply in Northern Ireland from their respective application dates; these EU Regulations will not apply in the rest of the UK.
The updates provide further information on the requirements for moving medical devices from Great Britain to Northern Ireland when the EU Regulations come into force. Anyone who brings devices for the first time into Northern Ireland from GB (or any other non-EU country) and places them on the market then they will be classed as an importer.
The guidance explicitly notes that there may be instances where the end customer, such as a hospital or dentist, may be considered to be the importer of the medical device.
Anyone classed as an Importer under the EU Regulations must comply with a number of legal obligations set out in the guidance, including verifying the regulatory status, documentation and labelling of the device; maintaining a register of complaints and cooperating with the MHRA as regards audits and field safety corrective actions. A full list of legal obligation of importers can be found in Article 13 of both EU Regulations.
In our experience, very few hospitals will be willing to accept the additional burdens of acting as importer.
It is likely that the MHRA has expressly stated that hospitals and dentists will in some cases be deemed to be importers of devices to emphasise the need to change existing supply chains. Many existing supply chains for devices enter Northern Ireland from Great Britain. Often hospitals purchased devices directly with GB suppliers (manufacturers or distributors). A supply chain such as this will result in the hospital or dentist being deemed the Importer and the obligations that this entails will apply.
This guidance services as another useful reminder of the need to revisit existing supply chains for products flowing from GB to NI.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.