Question for CE Marking of Medical Device (Directive 93/42/EEC)

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Brad Oh

We have a alcohol swab supplier. There is a history for this supplier for CE marking

[History]
1. CE certificate of the alcohol swab is completed on April of 2011.
2. The alcohol swab CE certified is manufactured at Jul of 2011 and the label of this product had no EC Rep information at that time. because they didn’t appoint EC rep..
3. The supplier has appointed certain company. as EC Rep on May of 2012.

I have a few question for CE marking process.

1. if manufacturer who is out of EU member states, can manufacturer put CE-mark on their products without designation of authorized representative in case of the product that was shipped to out of EU market?


2. if the product(stock) manufactured still exists currently at the time of when supplier didn’t have EC rep, can the swab supplier put the current EC rep information on the stock and sell them to EU market?
Otherwise, are only swabs manufactured after appointment of EC rep. able to be effective to apply EC rep. information on them and sell them to EU market?

3. proudct classification for alcohol swab is determined as Class IIa by its Decalaration of conformity (DOC) but intended use for the swab is to be a antiseptic topical skin cleanser prior to injection.
Is this wrong?
according to the classification of the non-invasive device on the 93/42/EEC, actual intended use might belong to class I.
in this case, can ClassIIa cover intended use of class I?

please advise me and give your opinion.

thanks
 
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pkost

Trusted Information Resource
There is no requirement to have an EC rep when you CE mark a product, only for when it is marketed in the EU. This is a common approach for organisations that want to market in countries outside the EU that recognise the CE mark, or for companies that intend to allow customers to own label

If there is old product that existed before appointement of the EC rep, it is acceptable to put them on the market if the EC-rep details are added and they were manufactured to the specification that the EC-rep has agreed to act for.

The classification would be I if it was only for the use you specify however swabs are commonly used surgically as well and this makes them IIa.
 
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