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Showing 5221–5230 of 62891 articles for “Art. 2-1° bis”
In carrying out certification procedures, manufacturers and approved bodies shall take account of the available results of any assessment and verification operations which may have been carried out, p…
The manufacturer or his authorised representative shall, for a period of at least five years and, in the case of implantable devices, at least fifteen years after the last copy of the product has been…
For the purposes of article L. 5143-3, a user approved to carry out the extemporaneous preparation of medicated feedingstuffs means the professional keeper of animals belonging to species whose flesh…
Files and correspondence relating to certification procedures are drawn up in French or in a language of a Member State of the European Union or party to the Agreement on the European Economic Area ac…
Where the conformity certification procedure applied by a manufacturer involves the intervention of an authorized body, the manufacturer may apply to the body of his choice within the framework of the…
Advertising of a medical device to healthcare professionals is tailored to the target audience. It specifies the date on which it was drawn up or the date of the last modification and includes at leas…
The equipment and services referred to in article L. 5232-3, the list of which and the conditions of issue of which are set by order of the Minister for Health, are classified into four categories: Ca…
The Agency's inspectors shall carry out inspections as decided by the Agency's Director General, who shall issue a letter of assignment to the inspector in charge of the investigation. This letter spe…
Repeated offences under article R. 5462-1 are punishable in accordance with articles 132-11 and 132-15 of the French Criminal Code.
Repeated offences under article R. 5461-1 are punishable in accordance with articles 132-11 and 132-15 of the French Criminal Code.
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