Implementing New Responsibilities for Economic Operators under the EU MDR

The MDR, published in in May 2017, has updated and clarified a variety of roles and responsibilities within the medical device supply chain, including those of economic operators. The Regulation defines an economic operator as a manufacturer, authorized representative, importer, or distributor and outlines new and increased responsibilities, which will be subject to greater regulatory scrutiny. These requirements have also broadened regulatory due diligence obligations from the manufacturer to other entities such as importers and distributors. In order to keep new and legacy products on the market, manufacturers must remain compliant with the MDR and fully understand the roles and responsibilities for each of these key players.

Manufacturer, Authorized Representative and Own Brand Labeling

  • Best practices for selecting a qualified representative
  • Methods to better prepare OBLs for new requirements
  • OBL contract provisions to permit full access and cooperation

Importer and Distributors

  • Reviewing general obligations for importers and exporters
    • Verification and validation
    • Labeling requirements
  • Responsibilities in post-market surveillance and vigilance
  • Applying checks and balances to demonstrate compliance

Erik Vollebregt
Axon Lawyers

Brooke AkinsContact:

Brooke Akins | Division Director, Life Science Programs
+1 (312) 224-1693