Where the authorised body encounters difficulties in implementing the conformity assessment procedures, it shall refer the matter to the Director General of the Agence nationale de sécurité du médicament et des produits de santé for specific recommendations on their application.
The decisions taken by the approved bodies under the procedures referred to in subsections 5, 6, 8 and 9 of section 6 of this chapter are valid for five years. They may be renewed for five-year periods on application submitted on the date contractually agreed between the manufacturer and the body. For duly justified reasons, the decisions of the approved body may be valid for less than five years. As…
Where an authorized body finds that the requirements of this Title applicable to this device have not been met or are no longer being met by the manufacturer, or where a certificate should not have been issued, it shall suspend or cancel the certificate issued or place restrictions on it, unless the manufacturer applies appropriate corrective measures to ensure that these requirements are met.
Authorised bodies shall inform the Director General of the Agence nationale de sécurité du médicament et des produits de santé of all certificates issued, modified, supplemented, suspended, withdrawn or refused. They shall make any additional relevant information available to the Director General on request. They inform the other organisations authorised in France or by any other Member State of the European Union or party to the Agreement on the European…
Any manufacturer having its registered office in France and who, in any Member State of the European Union or party to the Agreement on the European Economic Area, places class I medical devices or custom-made medical devices on the market in its own name, shall make a declaration to the Director General of the Agence nationale de sécurité du médicament et des produits de santé, indicating the address of its…
The declarations provided for in Articles L. 5211-3-1 and R. 5211-65 as well as the communication provided for in Article R. 5211-66 are made to the Agence nationale de sécurité du médicament et des produits de santé, by registered post with acknowledgement of receipt or by electronic means with acknowledgement of receipt. The declaration provided for in Article L. 5211-3-1 shall indicate the address of the declarant’s registered office, the…
The medical devices which must be notified in accordance with Article L. 5211-4 are class IIa, IIb and III medical devices and active implantable medical devices. The communication is made to the Director General of the Agence nationale de sécurité du médicament et des produits de santé when the medical devices are put into service on national territory, by the manufacturers, agents or distributors who supply the medical devices directly…
A natural or legal person who assembles devices bearing the CE marking, in accordance with their intended purpose and within the limits of use laid down by their manufacturers, in order to place them on the market in the form of a system or kit, shall draw up a declaration in which he certifies: 1° it has checked the mutual compatibility of the devices in accordance with the manufacturers’ instructions…
If a system or kit does not meet the conditions set out in Article R. 5211-67, and in particular if it contains devices not bearing the CE marking or if the compatibility of the assembled devices is not apparent from their manufacturers’ instructions, it is considered to be a device in its own right subject to the certification procedures.
The systems and kits are accompanied by the information mentioned in Article R. 5211-22, including, where applicable, the information supplied by the manufacturers of the devices that have been assembled. They do not have to carry an additional CE marking.
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75001, Paris France
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is a Registered Trademark of
PETROFF LAW FIRM (SELARL LEGASTRAT)
182, rue de Rivoli
75001, Paris France
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Paris Bar Registration n° (Toque) C2396
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