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Issued under Article 60 of Regulation (EU) 2017/745 (MDR)

Views:37 Date: May 15, 2026

Regulation (EU) 2019/1020 came into force on the 16th July 2021 and requires one of the following economic operators – Importer, Authorised Representative (AR) or Fulfilment service provider – to be located in the EU and their details presented with the product.
The Regulation makes it illegal to place certain products on the EU market unless a responsible EU-based economic operator is established. Manufacturers that currently sell, or offer to sell, directly to end users (both professional and consumer) in the EU, without an EU-based economic operator being involved, must appoint one before placing further products on the EU market.

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