Importing medical devices to EU, Germany

[michaelpui]

We are buying office.
Right now, we want to import suction unit (Class IIb) from other country to EU (mainly in Germany).
the manufacturer provided the cert of CE0123 and 13485 to us already.

Case I: import under our own brand
we know we should be the "manufacturer" under medical device directive if the device sold by us under our own name, but not produced by us.

in this way, could we just import to Germany?
what is the regulatory requirement for the relabeling /repacking of OEM product with our own brand name & selling distributing the same in various EU countries?

Case II: import under the manufacturer's brand
We are not the manufacturer now, so could we just import to EU? what is the regulatory requirement here?

Any help with this is greatly appreciated!

 

[somashekar]

So you are based in the EU.
Case I: import under our own brand
Get an OBL CE from a NB. Preferable is the 0123 NB itself. Register the device in Germany and Import and market. The labeling and packing in your name can also be done by the OEM.
Case II: import under the manufacturer's brand
Has manufacturer registered the device in Germany. Import and market.
Look at other regulations concerning to imports.
See into DIMDI

 

[michaelpui]

Thank you for your help !!

YES, we are based in EU!

Case I: import under our own brand
Get an OBL CE from a NB. Preferable is the 0123 NB itself.
-> so we apply for OBL by TUV SUD (0123) and they issue OBL CE cert (another 0123 CE cert) to us with our company name, right?

Register the device in Germany and Import and market.
-> registered by the national competent authorities?

Case II: import under the manufacturer's brand
Has manufacturer registered the device in Germany. Import and market.
-> the manufacturer provided us CE0123 which has EC representative in Germany already. is it ok?

Look at other regulations concerning to imports.
-> we think the following standards related
CE0123 (Directive 93/42/EEC on MDD, Annex V)
EN 13485
EN 980
EN 1041
EN ISO10993-1
YY 0636.1
EN ISO14971
EN 60601-1-2

 

[pkost]

As manufacturer in Germany you will have to notify the German competent authority that you are a manufacturer of medical devices. From recollection you have to appoint and inform the CA of a safety officer (see ? 30 MPG) - I'm not sure on the qualifications/competence required for this role

 

[michaelpui]

Thanks!

if we stick at Case II, then my company should not the manufacturer accordingly to MDD.
in this way, should we just import the medical device with CE0123 to Germany simply?

 

[wrodnigg]

In case II you only treade with medical devices which are CE-marked by the manufacturer.

Just make sure, that there is a valid CE certificate and a current declaration of conformity. You can order the products from the manufacturer and sell the im Germany.

But: you must not alter the labelling or instructions for use of the medical device.

 

[michaelpui]

Thanks
So for case ll
valid CE cert mean CE0123, right?

And
We have to keep the manufacturer's brand name to Germany