Medical Device (MedDev) Vigilance Guidelines for Importers into the UE

[ODISSEAS]

Hi friends,

once checked contents of april 07 edition of vigilance MedDev guidelines, I cannot find reference to role of importers into UE.

Briefly, if we act just as merely importers, not AR, obviously we must process complaints related with incidents reported by customer, communicating it to mfct. Also to competent authority?. Mfctr and AR is better?. For that cases, is suitable to use same wording (Field Safety Notice, v.g.) for our communications to authority and mafct?.

Thanks for your suggestions.

[burovoy]

Originally Posted by ODISSEAS

Hi friends,

once checked contents of april 07 edition of vigilance MedDev guidelines, I cannot find reference to role of importers into UE.

Briefly, if we act just as merely importers, not AR, obviously we must process complaints related with incidents reported by customer, communicating it to mfct. Also to competent authority?. Mfctr and AR is better?. For that cases, is suitable to use same wording (Field Safety Notice, v.g.) for our communications to authority and mafct?.

Thanks for your suggestions.

If you are merely an importer and not AR, as you say, then you are "a person responsible for placing devices on the market". You must report to the manufacturer and/or AR.

I would suggest you to look into your distribution agreement. The distribution agreement should regulate your reporting reponsibilities.

[ODISSEAS]

Thank you Burovoy,

then i would focus question to our company as regards to AR, or person responsible. Let´s suppose we are importing in parallel, that is, simultaneosuly with another companies and exists a pointed AR. As responsible person then we must and we can communicate incidents to authority, customers, manufacturer, and also we can determine any corrective action to be taken.

Ok, this is not a fascinating issue, but wich is common opinion?.

Thanks again.

[Roland Cooke]

First let's confirm exactly what your company does.

Do you import product that is manufactured outside the EU?

Do you sell the product untouched? (I.e. you do not repackage the product, do not put your company labels on the product, do not place a local language translation alongside the product, etc.)

Is there an European Authorised Representative identified on the product?

Do you have a distribution agreement directly with the manufacturer, or is there a middleman?

Does your distribution agreement cover regulatory and technical issues (especially complaints handling, control of translation, device recall procedures, distribution records control etc), or does it only deal with "simple" commercial arrangements?

[ODISSEAS]

Roland,

first a profile of my company:

- we are importing devices from outside UE, i expressed innaccurately but talking casually, goods from Union are just distributed since there not exists trade barrier.

- we are just re-selling devices, so we neither labell, no modificate them, being puting into service as manufacturers finishes process.

- we are dealing with around 15 products, from 5 different manufacturers, and most of them have pointed a different European Representative

- you asked about distribution agreement isssue, regretly it doesn´t exist for any.

So, in this situation, we are updating our vigilance procedure, but talking into account the satisfaction of my most important customer (as person named for this purposes): Competent Authority, who will check that in case of incident we are concerned with reporting and awarning to any involved part.

In short, here is my view: unless investigate causes and decide corrective actions, we must take all steps to communicate incidents or near so incidents.

Thanks again Roland, have a special day.

[Roland Cooke]

I would strongly advise that you create a standard regulatory agreement that you can use for all of your suppliers. (It can be an appendix to the existing commercial agreements if you like).

Your obligations are:

1) to confirm into which regulatory markets you sell (i.e. in the EU you should identify into which countries you sell). Ensuring the product has the correct labelling is a key reason for this.

2) to maintain appropriate records of distribution (i.e. in the event of a recall being required). You don't necessarily have to make this potentially-commercially-sensitive information available to your suppliers, but you should at least advise them that you have it.
For over-the-counter products, generally a list of final retailers is all that is expected to be maintained.

3) to forward any complaints, or any other kind of communication from the market, or from regulators, to the Authorised Rep and/or the original manufacturer.


Your suppliers' obligations are
a) to provide you with product that is legal for sale in the markets into which you sell.
b) to communicate to you any advisory notices (recalls, product information updates etc etc)
c) to ensure that you are meeting your regulatory obligations. (N.B. it is their legal responsibility).


This list is not necessarily conclusive of course.