Within the new EU legal framework (IVDR & MDR), an important responsibility is placed on the distributor as a distributor is considered as “economic operator” and therefore shall be compliant to requirements. According to the definition of “MAIDs” in the regulation, ‘Distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market, up until the point of putting into service.

Some Pre-Marketing and Post-Marketing activities shall be handled by the distributor itself, also relations with distributors and authorities are reinforced with regards to the application of the requirements of the regulations.

Medidee, can support you as distributor by:

  • Reviewing current distribution agreements and contracts, especially regarding the new regulations, both upstream (providers, manufacturers, importers) and downstream (third-party distributor, end-user)
  • Preparing internal procedures for compliance with the MDR / IVDR
  • Monitoring enforcement of regulations at national level

We also help medical device manufacturers search, select, qualify and manage medical distributors worldwide. With activities such as documentation, agreement setup, logistics processes implementation or distributor management on your behalf, whether you are entering a new market or expanding your distribution network, we can assist you with selecting high-quality medical distributors.