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”