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
- Who is placing a product from a third country on the EU market
- 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”