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Guiding Medical Device Manufactures through EU MDR 2017/745: Challenges and Strategies for Achieving CE Marking
The European Union (EU), comprising 27 member states and a consumer base exceeding 500 million, represents one of the most significant and advanced markets globally. For medical devices, CE Marking upon EC certification is mandatory for market access within the EU and the European Economic Area (EEA), establishing it as an essential certification for manufacturers aiming to enter this lucrative market.
The European Union (EU), comprising 27 member states and a consumer base exceeding 500 million, represents one of the most significant and advanced markets globally. For medical devices, CE Marking upon EC certification is mandatory for market access within the EU and the European Economic Area (EEA), establishing it as an essential certification for manufacturers aiming to enter this lucrative market.
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