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EU MDR is applicable to the European market. As is stated in the introduction: „As regards Article 114 of the Treaty on the Functioning of the European Union (TFEU), this Regulation harmonizes the rules for the placing on the market and putting into service of medical devices and their accessories on the Union market thus allowing them to benefit from the principle of free movement of goods“
So, if the manufacturer from Trinidad & Tobago wants to put a medical device on the EU market, that medical device must be in compliance and certified according to EU MDR.
For more information please read this article:
EU MDR – Easy-to-understand basics https://advisera.com/13485academy/what-is-eu-mdr/
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Mar 16, 2020