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Showing 2061–2070 of 51062 articles for “Art. II-6°”
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…
As part of the EC verification procedure, the manufacturer submits the devices manufactured for inspection by an authorised body. The authorised body checks the conformity of the medical devices with…
For the purposes of placing active implantable medical devices on the market, with the exception of those undergoing clinical investigations and custom-made devices, the manufacturer shall follow the…
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…
The manufacturer may instruct his authorised representative to initiate the following procedures: 1° Declaration relating to medical devices to be the subject of clinical investigations ; 2° EC declar…
For the purposes of placing medical devices other than active implantable medical devices on the market, with the exception of those undergoing clinical investigations and custom-made devices, the man…
For Class IIa medical devices or Class I medical devices, the provisions of Article R. 5211-43 apply subject to the following modifications: 1° For class II a medical devices, the authorised body veri…
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…
Organ transplants and haematopoietic cell transplants may not be carried out as part of the self-employed activities of statutory full-time practitioners as provided for in Article L. 6154-1.
Authorisation to carry out organ transplantation activities may only be granted to a health establishment meeting the conditions laid down in articles L. 1234-2 and L. 6122-2 if it has : 1° Full-time…
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