Requirements for Non CE-Marked product

[Mandy]

Our company manufacture and market CE marked products to the EU.

We now plan to market a product that is not CE-market for research use only. Since we are ISO compliant, we will manufacture and test the product in compliance with our quality management system.

Are there any regulatory or quality requirements that I should be aware of.

Thanks,
Mandy

 

[CBAL08]

Are we talking about medical devices?

 

[Pads38]

If you decide that your device is 'research only' so is not covered by the medical device directive you will still need to CE mark - but instead of the MDD you will need to comply with

1) The low voltage directive
2) The EMC directive
3) RoSH directive
4) WEEE directive

Each of these, in similar manner to the MDD has a set of 'Essential Requirements' and overlap a lot. For instance, there is a lot of emphasis on what could be called 'traceability'. That is, someone in any EU country should be able to readily identify and contact the manufacturer (and / or authorised representative) and the manufacturer should have clear and complete records for each model sold into the EU market.

Whereas the ERs for the MDD go on for several pages of detailed requirement, for these other directives the ERs tend to be only 1 or 2 pages, with a lot of overlap.

So - not quite so bad.

 

[Mandy]

No. It is part of an IVD not used for diagnostics.

 

[Mandy]

If you decide that your device is 'research only' so is not covered by the medical device directive you will still need to CE mark - but instead of the MDD you will need to comply with

1) The low voltage directive
2) The EMC directive
3) RoSH directive
4) WEEE directive

Each of these, in similar manner to the MDD has a set of 'Essential Requirements' and overlap a lot. For instance, there is a lot of emphasis on what could be called 'traceability'. That is, someone in any EU country should be able to readily identify and contact the manufacturer (and / or authorised representative) and the manufacturer should have clear and complete records for each model sold into the EU market.

Whereas the ERs for the MDD go on for several pages of detailed requirement, for these other directives the ERs tend to be only 1 or 2 pages, with a lot of overlap.

So - not quite so bad.

Our management is adamant about not CE marking. We do not expect a large sales volume for this product and it's not worth the money (they claim) to CE mark it.

Therefore I repeat my initial question - is there any regulatory or quality requirements that we need to follow.
If we don't CE mark, do we still need to look at the low voltage, EMC, RoSH and WEEE directives?

Thanks,
Mandy

 

[sreenu927]

As advised by Pads38, you need to be in compliance with those directives! Without CE marking, you can't ship any product into EU region.

Look for appropriate directives that are applicable to your product and ensure to meet them and apply CE Marking.

Regards,
Sreenu

 

[Mandy]

Our management is adamant about not CE marking. We do not expect a large sales volume for this product and it's not worth the money (they claim) to CE mark it.

Therefore I repeat my initial question - is there any regulatory or quality requirements that we need to follow.
If we don't CE mark, do we still need to look at the low voltage, EMC, RoSH and WEEE directives?

Thanks,
Mandy

I just want to clarify that this product is a DNA extraction kit - associated with an IVD device used for diagnostic purposes (but NOT used to diagnose).

I looked up the directives you mentioned above, and they do not seem to be pertinent to our product.

 

[Ronen E]

https://ec.europa.eu/health/medical-devices/files/meddev/2_14_2_research_only_product_en.pdf

 

[Mandy]

G'day mate
This is very helpful - exactly what I needed to see.
Thanks very much.
Mandy