Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

With regards to the EU's RoHS directive (Directive 2015/863/EU). As a contract manufacturer, can we self track the restricted substances and self-certify our compliance with the RoHS directive.

Or does our process absolutely require the evaluation of a 3rd party laboratory to declare compliance with RoHS3?

Thanks

Anon,

Typically this would be a self-declare process with all of the assessment, any needed testing, supporting documentation, materials specifications, etc., kept on file at the organisation for any queries which are made.  In my experience for medical devices there were only a few queries made which were most related to customer requests, not regulatory agency requests.  The customers are the ones in Europe usually needing confirmation or evidence the company has assessed and in compliance with RoHS.  Involvement of a third party laboratory may be needed if the raw materials or composition of the product is not clear for any restricted substances contained in/on the product.

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Richard Vincins ASQ-CQA, MTOPRA, RAC
Principal Strategy Consultant
NAMSA
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Original Message:
Sent: 03-Apr-2024 14:56
From: Anonymous Member
Subject: EU's RoHS self certifiction

This message was posted by a user wishing to remain anonymous

With regards to the EU's RoHS directive (Directive 2015/863/EU). As a contract manufacturer, can we self track the restricted substances and self-certify our compliance with the RoHS directive.

Or does our process absolutely require the evaluation of a 3rd party laboratory to declare compliance with RoHS3?

Thanks

Hi Anon,

the RoHS directive (2011/65/EU, the delegated directive 2015/863/EU is just one of the many updates the directive received) only references module A of Annex II to Decision No 768/2008/EC as way for the manufacturer to fulfill its obligations and that module basically covers the self-declaration procedure (technical documentation plus internal production controls). So there is no mandatory participation of a 3rd party laboratory required, as long as the manufacturer can justify their decision based on available information. For medical devices you would usually evaluate and document this in the Technical Documentation you generate anyway for the device and include the RoHS directive into your declaration of conformity (cp. MDR Article 19(2)).

Best regards, Christoph 

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Christoph Kiesselbach
Schrack & Partner
Reutlingen
Germany
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Original Message:
Sent: 03-Apr-2024 14:56
From: Anonymous Member
Subject: EU's RoHS self certifiction

This message was posted by a user wishing to remain anonymous

With regards to the EU's RoHS directive (Directive 2015/863/EU). As a contract manufacturer, can we self track the restricted substances and self-certify our compliance with the RoHS directive.

Or does our process absolutely require the evaluation of a 3rd party laboratory to declare compliance with RoHS3?

Thanks