Regulation (EU) 2019/1020 came into force on the 16th July 2021 and requires one of the following economic operators – Importer, Authorised Representative (AR), Manufacturer established in the EU 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.

• Represent your company before EU Competent Authorities

  
  

• Verify EU Declaration of Conformity and Technical Files

  
  

• Maintain compliance documents for 10 years

  
  

• Provide legal use of an EU-based registered address

  
  

• Liaise with EU authorities on your company’s behalf

  
  

• Manage product recall processes if needed.

• Over 10 Years of EU REP Expertise：We have established track records with extensive experience serving as EU Authorized Representative for medical device manufacturers worldwide.

• Full MDR Regulatory Compliance：We strictly operate in line with the latest MDR requirements to ensure complete regulatory compliance for your EU market access.

• Legally Registered Dutch Address: We provide an official, fixed legal address in the Netherlands with direct access to Competent Authorities, enabling faster and smoother regulatory communication.

  
  

• Audit and Annual Review Support：We offer proactive compliance reviews and full assistance during audits by notified bodies to help you maintain continuous EU market access.