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Importer and Distributor obligations under MDR

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Guest user Created:   Jan 22, 2021 Last commented:   Jan 25, 2021

Importer and Distributor obligations under MDR

We will be working with importers / distributors for our product. Possibly we will be importer or distributor ourselves for some products in future.

When checking MDR obligations for economic operators they should (amongst other obligations) perform a verification of medical devices they handle.

I have clear what needs to be documented for the verification but what I do not have clear is whether this verification obligation applies

  • to devices that ere CE-marked under MDD and MDR or
  • to devices that are CE marked under MDR only 

I highly appreciate your help, best regards,

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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

Expert
Kristina Zvonar Brkić Jan 25, 2021

Considering Article 120, Paragraph 3 from the MDR, requirements that will be applied to MDD CE marked medical devices after May 2021 are: post-market surveillance, market surveillance, vigilance, registration of economic operators. Therefore, verification obligations apply to devices that are marked under MDR, and not to ones under the MDD certificate.

For more information, see:

EU MDR Article 120 – Transitional provision - https://advisera.com/13485academy/mdr/transitional-provisions/

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Jan 22, 2021

Jan 25, 2021