11 May 2021
Graeme Tunbridge, Director of Devices at MHRA, has issued an open letter regarding importer obligations for Northern Ireland under the EU MDR.
The letter states that, following engagement with trade associations, the MHRA is aware that the new importer requirements “will create practical and logistical challenges when supplying medical devices into Northern Ireland”. Further, it acknowledges that the lack of guidance from the EU Commission is creating additional uncertainty.
Accordingly, the MHRA recognises that there will be a “period of adaptation” as suppliers adjust to the requirements and that it will, as the Competent Authority for Northern Ireland, “take a proportionate approach to compliance in cases where there is no risk to patient safety”.
We continue to engage with MHRA on behalf of industry in relation to the regulation of dental and medical devices in both Great Britain and Northern Ireland, and we will circulate any further updates or guidance as they become available.