Small enough to care and big enough to deliver

von LAUS GmbH

124 days until the new Medical Device Regulation

Which economic operator are you?

Have you checked your responsibilities?

Economic operators by definition:

  • Manufacturer or Manufacturer of Systems and procedure packs acc. Art. 22

 

Any natural / legal person established in the EU

 

  • Authorized representative:
    • By receiving a written mandate from the manufacturer
    • Who accepted the written mandate and is willing to fulfil their assigned and contractually defined tasks in the area of MDR
  • Importer:
    • Who is placing a product from a third country on the EU market

 

  • Distributor:
    • who provides MD products on the EU market
    • Except in defined cases: manufacturer / Importer

 

 

“Chapter I, Art 2, Regulation (EU) 2017/745 of European Parliament and Council from 05.04.2017 regarding MD”

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