Class I Medical Device - Need to notify CA (Competent Authority) if selling in Asia

[milagre]

Hi everyone,

I work for a small medical device company in Vietnam. We are planning to self-declare a Class I (not Class I*) medical device. Do we need to notify a Competent Authority of this if we do not intend to market the device in the EU? I think we do, but I am not sure. If it helps, we currently have a Class IIa device (infant phototherapy unit) on the market.

Notification of a CA is mentioned in step 6 here (http://ec.europa.eu/health/medical-...ives/notes-for-manufacturers-class1-09_en.pdf) among other places.

 

[pkost]

Re: Class I device - need to notify CA if selling in Asia

If you are not in the EU and are not intending to market the product in the EU you do not have to comply with any European requirements including (not not limited to) applying the CE mark or notifying a european competent authority.

If you are selling into a market that assumes compliance with local regulations for products that have a European CE mark, this is a different discussion and you would need to clarify with more specific information

 

[milagre]

Re: Class I device - need to notify CA if selling in Asia

Some of our potential-customers require CE marks for devices they are purchasing. For example, a government tender could list one of the required specs as a CE-marked device. These customers are not in countries that have officially adopted the MDD, but the buyers require it for devices they purchase. Our motivation is to meet the requirement of these buyers.

For our currently CE marked class IIa medical device we work with a NB in Slovakia. I understood from reading that Class 1 devices without measuring functions could be self-declared without involvement of a NB, but I am not sure how we go about notifying the Competent Authority ourselves, and I am also not sure if it is necessary for us to do so, considering we don't plan to sell to the EU or to countries that have adopted the MDD as law.

I'm not really sure if gave the specific information you were looking for. If I didn't perhaps you could specify what kind of info you would be necessary to better understand my question.

 

[pkost]

Re: Class I device - need to notify CA if selling in Asia

As a manufacturer based outside of the EU, it would normally be the responsibility of your authorized representative to notify the CA in their own country. It is not possible for you to notify a CA except via the EC-rep.

You pose an interesting question. In order to affix a CE mark you must demonstrate compliance with the Essential requirements and follow the appropriate conformity assessment routes.

My reading of the MDD suggests that you only have to notify the CA if you intend to market the product in the EU. They are separate and distinct activities,

Relevent articles from MDD:

11: conformity assessment procedures
14: registration of persons responsible for placing devices on the market
17: CE marking

I would therefore suggest that you don't have to notify a CA, although it will be interesting to see the opinion of others on this forum

 

[milagre]

Re: Class I Medical Device - Need to notify CA (Competent Authority) if selling in As

it will be interesting to see the opinion of others on this forum

Agreed. I'd be interested to hear from others as well. This reply is more of a "bump" thank anything, but I really do appreciate your answers pkost.