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Dear Madam(s) / Sir(s),

I hope this email finds you well.

I am reaching out to you with regards to registration requirements for distributors of medical devices per EU MDR.

We seek guidance on the following question:

Would a company located outside Estonia (but in the EU) be required to register as a distributor of medical devices in Estonia in addition to their registration in another EU country?

The scenario would be as follows: a medical device already on the EU market (but outside Estonia) will be distributed to a healthcare facility for a defined timeframe within a drug clinical trial. After the trial ends, the device will be shipped back. The device is CE marked and not in scope of the clinical trial or clinical investigation, but only used for collection of clinical data to support trial endpoints.

 

In this scenario, would the distributor located in another EU country (and already registered in that country) be required to register in Estonia as well?

 

Thank you very much in advance for your kind feedback and response.

 

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