Implantable medical devices, active implantable medical devices and class III devices must be subject to clinical investigations, unless the use of existing clinical data can be duly justified.
The manufacturer who intends to have clinical investigations carried out in France to verify the performance of a medical device or to detect any undesirable side effects, or his authorised representative established in a Member State of the European Union or party to the Agreement on the European Economic Area, must, before undertaking his investigations : 1° Certify, in accordance with the procedures defined in Article R. 5211-38 , that…
As part of the procedure applicable to medical devices undergoing clinical investigations, the manufacturer shall draw up a declaration containing the information referred to in Articles R. 1123-37 to R. 1123-41 and certifying that the medical device concerned complies with the essential requirements defined in Section 5 of this Chapter, with the exception of the aspects to be investigated and for which he certifies that all precautions have been taken…
As part of the EC declaration of conformity procedure, the manufacturer shall draw up technical documentation making it possible to assess the conformity of the medical device with the essential requirements set out in Section 5 of this Chapter. The manufacturer shall establish and keep up to date a systematic procedure for examining the data acquired on medical devices and shall apply the necessary corrective measures. For Class I medical…
As part of the procedure for the EC declaration of conformity, a full quality assurance system, the manufacturer must submit to an approved body for verification the quality system which he has set up for the design, manufacture and final inspection of the medical devices and the application of which must guarantee compliance with the provisions of this Title and the implementing orders which apply to them. The manufacturer submits…
For Class IIa devices, the authorized body must, as part of the assessment of the quality system, assess the technical documentation for at least one representative sample of each device subcategory in order to verify its conformity with the provisions of this Title. For Class II b devices, as part of the assessment of the quality system, the authorized body must evaluate the technical documentation for at least one representative…
As part of the EC type-examination procedure, the manufacturer must submit to an authorized body for examination a representative sample, called a type, of the production envisaged in order that the body may check that this sample satisfies the essential requirements defined in Section 5 of this Chapter which apply to the devices under consideration. The manufacturer must submit an application for assessment to an authorized body, which must include,…
For the purposes of the EC declaration of conformity procedure referred to in the first paragraph of Article R. 5211-40 and the EC type-examination procedure referred to in the first paragraph of Article R. 5211-41, in the case of a medical device or an active implantable medical device manufactured utilising tissues of animal origin referred to in Article R. 5211-23-1, the authorised body shall assess, in accordance with the procedures…
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 an approved type described in an EC type-examination certificate referred to in Article R. 5211-41 or with the technical documentation referred to in Article R. 5211-39 under the conditions described in this sub-section. In addition, in the case of medical…
In the case of active implantable medical devices or medical devices in Class III or Class II b, the manufacturer shall take all necessary measures to ensure that the manufacturing process guarantees conformity of the medical devices manufactured with the type described in the EC type-examination certificate and with the essential requirements defined in Section 5 of this Chapter which apply to them. He shall draw up technical documentation relating…
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is a Registered Trademark of
PETROFF LAW FIRM (SELARL LEGASTRAT)
182, rue de Rivoli
75001, Paris France
RCS Paris n°814433470
Paris Bar Registration n° (Toque) C2396
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is a Registered Trademark of
PETROFF LAW FIRM (SELARL LEGASTRAT)
182, rue de Rivoli
75001, Paris France
RCS Paris n°814433470
Paris Bar Registration n° (Toque) C2396
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