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In the new IVDR & MDR of the EU, an important responsibility is placed on the distributor as a distributor is considered as “economic operator” and therefore shall be compliant to requirements. '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.

WMDE B.V. can assist in bringing your current distribution agreements and contracts in compliance with the upcoming MDR & IVDR.