What you need to know about the new EU Regulations for medical devices (MDR) and in vitro diagnostic medical devices (IVDR), and their implementation in Northern Ireland.
Brexit is official, the United Kingdom has left the European Union. But what does that mean for Northern Ireland? In Northern Ireland, the CE mark remains valid, so CE marked devices can be placed on the market and they fall under the jurisdiction of the European Court. Whereas market surveillance will be performed by the UK Medicines and Healthcare products Regulatory Agency (MHRA).
Non-EU companies wanting to take part in the European market can keep relying on an Authorized Representative based in Northern Ireland for placing their devices on that market as well as the rest of the EU. But who can place Medical Devices on the Northern Ireland market? Only an importer based in Northern Ireland can do that, but the UK Responsible Person (UKRP) may be based anywhere in the UK.
Regarding the subject the UK Medicines and Healthcare products Regulatory Agency (MHRA) published a new version of their guidance document for placing devices on the Northern Ireland market. The document clarifies the roles of the importer, distributor, and manufacturer by directly referencing the Medical Devices Regulation (MDR) and the In-vitro Diagnostic Medical Devices Regulation (IVDR), meaning that the importer must comply with Article 13, distributors must comply with Article 14 and manufacturers or their Authorized Representative (AR) must comply with Article 15 regarding the Person Responsible for Regulatory Compliance. All these requirements will apply when the MDR/IVDR become fully effective, for the MDR that date is May 26, 2021 and for the IVDR May 26, 2022. The guidance documents also specifies that Northern Ireland based distributors, such as drugstores or supermarkets my be acting as importers.
Get the full guidance document here: Click
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