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Hello! Well I have another question on the Northern Ireland Protocol, Brexit and Article 120 of the MDR. My company, which is based in Arizona, is in the process of transitioning to the MDR. Our current MDD-based EC Certificate expires in January 2023. We have received lots of guidance with respect to Article 120, and the transition requirements, and note that it is possible to ship product to a EU-based distributor before the expiration of the EC Certificate, and that will meet the requirements of "placing on the market", and it will be acceptable to continue to make these products available within the EU until May 26, 2025. However, our current distributor is based in North Ireland.
As it relates to placing product on the UK market I am aware of the guidance that differentiates the "UK" from "Great Britain - GB", and the "UK CA" mark versus "UK NI" mark. What I am not confident of is whether placing the device into our distributor in Northern Ireland would be considered placing the product on the EU market, and thus whether it is possible to create an inventory at the distributor in NI before EC Certificate expiry and then ship into the Member States of the EU. Would NI in this scenario be considered a "Member State"? I can't find a solid reference that provides a Yes/No/Maybe answer, and therefore, any assistance that can be provided is greatly appreciated.