French Public Health Code
In forceFor the purposes of this sub-section, the following definitions apply:
1° Perforating waste from healthcare activities: any waste from healthcare activities with infectious risks meeting the requirements of a of 2° of Article R. 1335-1;
2° Medicinal product: any medicinal product within the meaning of Article L. 5111-1, whether or not combined with perforating medical devices within the meaning of 3° of this article, or with electrical or electronic equipment within the meaning of 4° of this article, the use of which leads directly to the production of healthcare waste and the name or pharmaceutical form of which indicates that it is administered by injection or parenterally, whether or not including the injection equipment or device, which may be self-injected by the patient himself or administered by those around him without the intervention of a health professional and used in the treatment of one of the pathologies appearing on a list drawn up by order of the Minister for Health after obtaining the opinion of the Agence nationale de sécurité du médicament et des produits de santé (National Agency for the Safety of Medicines and Health Products);
3° Perforating medical devices : all perforating medical devices and all perforating in vitro diagnostic medical devices within the meaning of 9° of article L. 541-10-1 of the Environment Code, including those incorporating as an integral part a substance which, if used separately, would be considered as a medicinal product, whether or not associated with electrical or electronic equipment, and whose use by self-treatment patients and users of the self-tests mentioned in article L. 3121-2-2 of the present code leads to the production of waste from healthcare activities involving perforating infectious risks within the meaning of this 1°;
4° Electrical or electronic equipment associated with a perforating medical device: equipment required for the injection of a medicinal product or the operation of a perforating medical device within the meaning of 3°, the use of which leads to the production of waste from electrical or electronic equipment presenting an infectious risk within the meaning of 1° of article R. 1335-1 or of a perforating nature within the meaning of 1° of this article;
5° Producers, within the meaning of I of article L. 541-10 of the Environmental Code, of a medical device mentioned in 3° of this article: all operators mentioned in 3° of article R. 5124-2 of the present code and all manufacturers or their representatives within the meaning of :
a) 30° or 32° of Article 2 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017, as amended, concerning medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC ;
b) or 23° or 25° of Article 2 of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU.
In the event that an armour-piercing medical device referred to in 3° of this article is sold under the trademark or trade name of a reseller or principal whose trademark or trade name is affixed under a contractual document, this reseller or principal is considered to be a producer;
6° Safety perforating medical devices, within the meaning of article R. 1335-8-7: all medical devices with an integrated system for covering the penetrating part in order to limit the risk of injury to the user.
