CE Mark requirements for Class IIA MDs - European medical devices importers

[ODISSEAS]

1. We are european medical devices importers.

2. We are dealing with an east stainless steel resterilizable surgical devices manufacturer.

3. As class IIa devices, a NB is not needed, so a self-declaration is enough to document conformity with MD directive. But, who signs it? Importer (thus becoming manufacturer)? Manufacturer (not skilled at all on regulatory grounds)?

4. In first case, wich part needs to implement a QMS? Legal manufacturer or fact manufacturer?

5. In second one, can we provide them with a blank declaration ready to sign?


Thousand tnks for any suggestion¡¡¡¡¡

[Al Rosen]

Originally Posted by ODISSEAS

1. We are european medical devices importers.

2. We are dealing with an east stainless steel resterilizable surgical devices manufacturer.

3. As class IIa devices, a NB is not needed, so a self-declaration is enough to document conformity with MD directive. But, who signs it? Importer (thus becoming manufacturer)? Manufacturer (not skilled at all on regulatory grounds)?

4. In first case, wich part needs to implement a QMS? Legal manufacturer or fact manufacturer?

5. In second one, can we provide them with a blank declaration ready to sign?


Thousand tnks for any suggestion¡¡¡¡¡

I think you may need to read the MDD again as I believe that with a class IIa device you need a Notified Body. Which Annex are you planning on meeting?

[ODISSEAS]

Thank you, Moderator, for underline my double mistake, one that you appointed, and second one relating to classification, since most of devices concerned seems to fall in class I (according to rule 6).

So, can I reelaborate my question? Where it says "class IIa" must say "class I".

[Microbe]

Do you supply the device sterile? If so then you will still need a Notified Body

[ODISSEAS]

Tnx, Micro. Not sterile, is well known that requirement for sterile and measurement devices, but who is responsible of self-declaration? The importer company who puts in the market?. If so, I guess that a QS based on 13485 is needed, and real manufacturer must be the bearer of the certificate, otherwise our company becomes in a european manufacturer with factory located out of Europe, and we support costs of implementation. . . for a few thousand pieces of surgical stainless steel.

A third way, just as a question to forum mates, is to draw and sign declaration but as authorized representaive in Europe, provided that one is needed to be appointed and probably manufacturer will propose our own company. Still in this case I cant see clearly the way to show conformity with essential requierments.

Uff, guys, . . .

[chris1price]

Hi

If the product is Class1, non-sterile there is no requirement for a ISO13485 quality system. Someone needs to put together a technical file for each product. Annex VII, Paragraph 3 lists what is required in the file.

The manufacturer needs to appoint someone in Europe as their representative. This is probably yourself. When you get their Technical File and are happy that it meets para 3, you can then raise and sign the Declaration yourself.

Note that someone must maintain procedures for post-market surveilance. The MDD says that this is the manufacturer, but this could be delegated to yourself as the Authorised Representative.

Depending on where you are located, you may also have to register with the local Competant Authority.

Finally, the MHRA have a useful guidance document for manufacturers of class 1 devices.

Good luck

[ODISSEAS]

Thanks a million for your usefull info. Regards.