ROHS 2 - Medical Device: Placing vs Making Available on the market

[dionysisf]

Hello,

We are a medical device manufacturer and we are in the process of transitioning to the ROHS 2 compliant devices which we are ablidged to place on the EU market after 22/07/14.

The question is:
In case we sell to our EU distributors non-ROHS 2 compliant products prior 22/07/2014, can the distributor make it available on the EU market after 22/07/14?

In other words, we (the manufacturer) place the non-ROHS2 device on the market on 21/07/14. Can the distributor make the non-ROHS2 device available on the market on 23/07/14?

Thanks in advance for your responces!

 

[Ronen E]

Hello,

We are a medical device manufacturer and we are in the process of transitioning to the ROHS 2 compliant devices which we are ablidged to place on the EU market after 22/07/14.

The question is:
In case we sell to our EU distributors non-ROHS 2 compliant products prior 22/07/2014, can the distributor make it available on the EU market after 22/07/14?

In other words, we (the manufacturer) place the non-ROHS2 device on the market on 21/07/14. Can the distributor make the non-ROHS2 device available on the market on 23/07/14?

Thanks in advance for your responces!

Hi,

The cutoff date for medical devices (22.7.2014) relates to Placing On The Market.

If you are inside the EU, your sale to a distributor inside the EU is probably considered Placing On The Market (consult the Blue Guide 2014 s. 2.2 & 2.3 for a definite answer), and their further sale / offer in the EU is only considered Making Available On The Market. In such a case you may sell non-compliant medical devices on 21.4.2014, and they may further distribute after the cut-off date.

If you are outside the EU, the first entity to take title in the EU is considered an Importer, and as such they would be considered the ones Placing On The EU Market, when they transfer ownership of your devices to others in the EU. In that case they will have to make their transaction before 22.7.2014, in order to comply.

In short, if you are inside the EU then the answer to your last question is Yes. Otherwise, No.

Cheers,
Ronen.

 

[Pads38]

On this subject it may be significant to consider a directive that modifys RoSH2; this being directive 2014/13/EU

This creates an exemption for lead on PCBs for mobile medical devices (class IIa and IIb) until 30th June 2016

See here:
http://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32014L0013&from=EN

 

[dionysisf]

Hello,

I would like to thank you very much for your responses and for your useful guidance!

Best regards