Importing Medical devices class I in EU

S

sss16

#1
Hello all!

We want to import medical devices class I, but they give us Compliance report and strange declaration of conformity . There is no CE marking.The factory is in China.

We are importing class IIA medical devices from China which are CE marked and with CE and Declaration of conformity looking normal.

The chinese say that they have import in EU countries and that it is so with MD class I.

We have never imported MD class I.

Any help will be heartly appreciated.
 
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chris1price

Trusted Information Resource
#2
Hi, If the devices are Class 1 and are not sterile and do not have a measuring function, then they are "self certified" by the manufacturer and there is no certification by a Notified Body. In this case, the CE Mark on the product and label will have no number after it.

If the product is sterile or has a measuring function, then there should be a number after the CE Mark and you should have a CE Certificate from a notified body.

You may also want to check they have an "Authorised Representative in EU". Their name and address should be on the label.

These pages by MHRA may be of use:

Guidance on class 1 medical devices - GOV.UK
Register as a manufacturer to sell medical devices - GOV.UK
 
S

sss16

#3
The device is electrical wheelchair and hospital bed.

The manufacturers already made import in EU.

The goods are non sterile and without measuring function...

They give us Compliance report and declaration of conformity.

Our other supplier with IIa class is giving us different CE and declaration of conformity.

They come not CE marked... we have stickers and the suppliers propose to put. But do they have a right to do it.


They don't have EU representative it will be a problem?


Thanks for the reply and the help, because we were shocked and cannot meet our lawyer asap.
 

chris1price

Trusted Information Resource
#4
Hi,

Have they given you a procedure for applying the labels? The label or device must have a CE Mark on it somewhere.

A EU Authorised Representative is compulsory for manufacturers outside of EU. There should be an agreement between the manufacturer and the Authorised Representative describing their duties and the Authorised Representative will have to register with their national Competent Authority.

From what you are describing, I would be very cautious about selling these products.
 
S

sss16

#5
How it's possible they sell on the EU market.

Today we have consultation with our lawyer.

Thanks for the reply!
 
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