Accessories Listed on MDR Certificate?

[REGULATED]

Hi everyone!,

good morning, I would like to share this query with you and get a collective opinion.
Customs officials have blocked the entry into the EU (at the level of our country) of a medical device on the grounds that the CE certificate under MDR 2017 does not include all the accessories related to the main equipment. This seems to us to be a never seen situation, and in any case the Notified Body is not going to initiate any action to amend its certificate. Both manufacturer and us as importers, can not provide a direct justification.

Hearing your knowledge and perspective would be very important...

Thnks!

 

[d_addams]

Hi everyone!,

good morning, I would like to share this query with you and get a collective opinion.
Customs officials have blocked the entry into the EU (at the level of our country) of a medical device on the grounds that the CE certificate under MDR 2017 does not include all the accessories related to the main equipment. This seems to us to be a never seen situation, and in any case the Notified Body is not going to initiate any action to amend its certificate. Both manufacturer and us as importers, can not provide a direct justification.

Hearing your knowledge and perspective would be very important...

Thnks!

Is the issue the accessories that are included in the shipment are not listed on the CE cert or that the device of interest does not list the necessary accessories on its CE cert.

Does the device of interest in fact have required accessories?
How did the customs agents determine this? Are the required accessories listed in the labeling of the device of interest?