French Public Health Code
In forceI.-This sub-section implements the principle of extended producer responsibility, provided for by the provisions of article L. 4211-2-1 and those of I of article L. 541-10 of the Environment Code, to which the producers of perforating medical devices referred to in 3° of article R. 1335-8-1 of the present code are subject, subject to II of the present article, and defines the procedures for managing the waste from these devices.
II.- By way of derogation from I, the provisions of the present sub-section do not apply to waste from electrical or electronic equipment associated with a perforating medical device when this waste does not present an infectious risk and is not perforating.By way of derogation from I, the provisions of this sub-section do not apply to waste from electrical or electronic equipment associated with a perforating medical device when this waste does not present an infectious risk and is not perforating. In this case, such waste is covered by the provisions laid down in application of 5° of article L. 541-10-1 of the Environment Code.
III. -It is the responsibility of producers to justify that their waste covered by II meets the following conditions:
1° If the producer applies for its product to be registered as a brand or trade name on the list provided for inarticle L. 165-1 of the Social Security Code, it must attach to the file referred to in article R. 165-7 of the same Code a form containing information to justify the absence of any infectious or perforating risk, together with a declaration on its honour relating to the accuracy of this information. In the absence of these two documents, the waste is subject to the provisions of this sub-section;
2° If the producer does not apply for its product to be registered as a brand or trade name on the list provided for in the aforementioned Article L. 165-1, in particular when the product is self-registered on an existing generic line, it must send the form containing the supporting information and the declaration on its honour provided for in 1° to the Minister for Health before placing its product on the market. In the absence of receipt of these two documents, by any means giving a certain date of receipt, the waste is subject to the provisions of this sub-section.
