New Battery Regulation

[AngelRose]

Hi guys,

I need clarifications regarding Regulation EU 2023/1542...
My medical device incorporates a small battery, not end-user accessible or repleaceable.
However a client is requiring me to conduct checks in accordance to Article 42, which outlines obligations of distributors.

According to Article 1(3):
"This Regulation [...] also applies to batteries incorporated into or added to products [...]."

Based on this, I could be considered an economic operator according to this Regulation, as I make available on the market a device that incorporates a battery - Article 3(17)
(17) ‘making available on the market’ means any supply of a battery for distribution or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge;

Following this interpretation, I would fall under the definition of a distributor Article 3(65) since I'm neither a manufacturer Article 3(33) nor an importer Article 3(64) of the battery.

If this were to be the case, I'm required to comply with Article 42 obligations.
However I'm trying to contest this because I believe that the definition of "making available on the market" is a technicality that does not necessarily imply I take an active role in the supply chain for the purposes of the Regulation.

What do you think?
Thank you in advance for your support...

 

[ChrisM]

If the small battery is not end-user accessible or replaceable, you are not making the battery available on the market... you cannot buy or obtain for free" the battery on its own

 

[AngelRose]

If the small battery is not end-user accessible or replaceable, you are not making the battery available on the market... you cannot buy or obtain for free" the battery on its own

What do you suggest our role should be? Do you recommend that we document the Battery DoC, RoHS Declaration, and MSDS in the Technical Documentation? Should we add in our DoC that we are compliant to the Battery Regulation?

Thanks!

 

[yodon]

I guess I could use some help understanding.

a client is requiring me to conduct checks

Is the client an end user of the medical device?
What "checks" do they want, in particular?

 

[AngelRose]

I guess I could use some help understanding.

Is the client an end user of the medical device?
What "checks" do they want, in particular?

Hi yodon! The client is a distributor, not yet an end-user.
They would like us to provide a report assessing compliance with Article 42, distributor requirements.

 

[yodon]

Ah, then I would agree with @ChrisM that you're not making the batteries available on the market.

They should know any relevant storage and transportation requirements (at least) so what you describe should probably cover their needs.

 

[EmiliaBedelia]

Do you recommend that we document the Battery DoC, RoHS Declaration, and MSDS in the Technical Documentation? Should we add in our DoC that we are compliant to the Battery Regulation?

I think you should document these things in your technical documentation. Have you submitted your device for MDR yet? Your NB will likely ask about compliance of the battery, so you should make sure that is documented for your own purposes as a device manufacturer. You also will need to include any special storage/disposal requirements regarding the battery in your IFU so you need this info regardless.

If the battery is already compliant in its own right and you are using it in accordance with its intended purpose, it should be straightforward for you to document what the battery manufacturer has already done. Clause (64) of the regulation clearly states that compliance does not need to be demonstrated twice for the same product so you shouldn't need to recreate the same documentation from the battery manufacturer.

If your client is acting as the actual "distributor" in this case, they are responsible to do those same checks on their side before they can distribute the device, so it makes sense why they are asking for this information.

 

[AngelRose]

Thank you everyone for your input.
Everything is clearer to me now.