RoHS Directive 2011/65/EU Revision ? Medical Devices - 22nd July 2014

[missjenny]

"As far as what I know of Blood Glucose Monitoring Devices, its components such as lancets/lancing devices and test strips are also sold separately. Under Q 7.3 in the FAQ document it is stated that stand alone components do not require to be in compliance. This "may" apply to these components and hence put them out of scope. Hopefully, someone with experience can add to this."

- The important part here is the term "stand alone." What does this mean? Does it simply mean that it is also sold separately or that they must be able to function or perform alone without the other components? If it is the latter, then obviously it will be in scope. Please help?

 

[redknight07]

For devices that are intended to be sold outside of Europe and have a CE mark, what are the implications if the device is not RoHS compliant? Since this is a requirement only for devices headed to the EU, then should the CE mark be taken off the non-RoHS compliant devices headed to non-EU countries?

My opinion is that this would not be necessary since RoHS compliance is a requirement only for EU and as far as non-EU countries are concerned then devices can carry a CE mark even if non-RoHS compliant. Any suggestions on this?

Feedback most welcome.

Thanks,
Aniket

 

[Ronen E]

For devices that are intended to be sold outside of Europe and have a CE mark, what are the implications if the device is not RoHS compliant? Since this is a requirement only for devices headed to the EU, then should the CE mark be taken off the non-RoHS compliant devices headed to non-EU countries?

My opinion is that this would not be necessary since RoHS compliance is a requirement only for EU and as far as non-EU countries are concerned then devices can carry a CE mark even if non-RoHS compliant. Any suggestions on this?

Feedback most welcome.

Thanks,
Aniket

Hi,

This is a general question which exceeds the RoHS aspect. Let me rephrase please:

"Is it acceptable to market CE mark bearing devices in countries outside the EC while those devices are not fully compliant with all applicable CE mark related EC legislation?"

This question has been discussed here several times, and a search might yield useful answers. In short, it is problematic and in some cases - non-EC countries that formally rely on CE marking for regulatory market clearance - it's completely unacceptable.

In my personal view it's a form of deception. You will be making a statement that isn't true.

Cheers,
Ronen.

 

[redknight07]

Hi,

This is a general question which exceeds the RoHS aspect. Let me rephrase please:

"Is it acceptable to market CE mark bearing devices in countries outside the EC while those devices are not fully compliant with all applicable CE mark related EC legislation?"

This question has been discussed here several times, and a search might yield useful answers. In short, it is problematic and in some cases - non-EC countries that formally rely on CE marking for regulatory market clearance - it's completely unacceptable.

In my personal view it's a form of deception. You will be making a statement that isn't true.

Cheers,
Ronen.

Thank you for the clarification, Ronen. I do follow that for a device to bear a CE mark, it has to comply with all the requirements mandated as per the European Directive.

For approval/registrations in non-EU countries, if the devices have a CE mark or approval/clearance in the US, then the registration process is relatively easy due to the extensive requirements for approval in US or in the EU. What possibly could be the impact if the CE mark had to be taken off for devices headed to these countries! Notifying the authorised representatives? Contacting the regulatory bodies? Re-registering the devices? Maze.

 

[Ronen E]

Hi,

The answer depends on whether the (non EC) country of interest relies on the CE mark in its regulatory clearance process.

If it doesn't - I reckon that you can take away the CE mark without notice, provided that that action doesn't afect any significant aspect of the device. At most, document a letter to file with your reasoning for not notifying any one.

If it does - you'd probably need to re-clear on the merits of the device itself, without its (obsolete) CE marking.

Cheers,
Ronen.

 

[Welshgar]

Re:implications of use of non CE medical devices

Steve,

I am new to the forum so not sure about route to post questions to correct discussion.

I am an audiologist and many colleagues are now using suction equipment for a purpose it was not specified for and there is no equipment available in the UK with CE approval or that manufacturers will give approval to for this use. What are the legal and personal implications?

 

[Ronen E]

Re: implications of use of non CE medical devices

Steve,

I am new to the forum so not sure about route to post questions to correct discussion.

I am an audiologist and many colleagues are now using suction equipment for a purpose it was not specified for and there is no equipment available in the UK with CE approval or that manufacturers will give approval to for this use. What are the legal and personal implications?

Try here

 

[Welshgar]

The manufacturer and country of use is the UK?

 

[Ronen E]

The manufacturer and country of use is the UK?

MHRA = UK's official Medicines and Healthcare products Regulatory Agency.

http://www.mhra.gov.uk/Aboutus/index.htm

The country where the manufacturer is located is irrelevant in that regard.

Cheers,
Ronen.

 

[Critical Care]

HI Steven K,

Does a MD manufacturer must have a seperate DoC for the RoHS directive or the CE DoC is enough ?