CE Mark outside of Europe - Implications

[Mark Meer]

What are the implications of a CE mark on a device if it's NOT being marketed/sold/distributed in Europe?

Hypothetical situation:
- Device goes through NB and approved to mark with CE.
- The CE Mark is then pre-printed on all labels & packaging.
- After a few years, decision is made to discontinue with Europe market due to low sales. NB contract is allowed to expire.

In the situation above, must all the pre-printed labels and packaging be discarded (& re-designed without the CE mark)? ...or can they continue to be used as long as the units aren't being marketed/sold/distributed in the EU?

 

[MIREGMGR]

Re: CE Mark outside Europe implications

I can't cite specific law, but I'd think you'd have to avoid marketing in the many non-EC countries where Customs and/or the medical device regulatory authorities regard the CE Mark as a quality/regulatory credential. Otherwise the authorities in such a country might consider you to have made a fraudulent labeling statement.

 

[somashekar]

Re: CE Mark outside Europe implications

What are the implications of a CE mark on a device if it's NOT being marketed/sold/distributed in Europe?

Hypothetical situation:
- Device goes through NB and approved to mark with CE.
- The CE Mark is then pre-printed on all labels & packaging.
- After a few years, decision is made to discontinue with Europe market due to low sales. NB contract is allowed to expire.

In the situation above, must all the pre-printed labels and packaging be discarded (& re-designed without the CE mark)? ...or can they continue to be used as long as the units aren't being marketed/sold/distributed in the EU?

While the CE mark along with the NB number is a requirement to place the devices in the EU, the use of CE mark along with the NB number is not the property of the manufacturer. The agreement between the manufacturer and the NB is limited to using the CE mark upon issue of the EC certificate. Once it expires / withdrawn from a specific date, the manufacturer is not supposed to use the mark + NB number on the device. Where the device is sold / distributed does not override.

 

[Mark Meer]

...you'd have to avoid marketing in the many non-EC countries where Customs and/or the medical device regulatory authorities regard the CE Mark as a quality/regulatory credential...

What non-EC countries' regard the CE mark as a quality/regulatory credential?
...I didn't think the CE mark had any applicability outside the EC...

Once it expires / withdrawn from a specific date, the manufacturer is not supposed to use the mark + NB number on the device...

What about for a self-declared CE mark (for which the original declaration no longer applies)?

 

[somashekar]

What non-EC countries' regard the CE mark as a quality/regulatory credential?
...I didn't think the CE mark had any applicability outside the EC...

Take for example India. Many tenders for supply of medical devices here ask for the CE mark on the device.
Lot many countries grandfather the CE mark, simply because it is believed that if its good for the Europe, its good for them as well.

What about for a self-declared CE mark (for which the original declaration no longer applies)?

No NB number, no legal binding. Now all that matters is one's own conscious. People elsewhere are getting smarter and now know a bit of device classification and need of a NB (NB number) to be associated with the CE mark. Usually a valid CE certificate is asked to be submitted for the tender approvals.