Article R5211-51
As part of the procedure applicable to custom-made medical devices, the manufacturer must draw up documentation including the name and address of the manufacturer, the place or places of manufacture,…
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Showing 2541–2550 of 51062 articles for “Art. II-6°”
As part of the procedure applicable to custom-made medical devices, the manufacturer must draw up documentation including the name and address of the manufacturer, the place or places of manufacture,…
For Class IIa medical devices or Class I medical devices, the provisions of Article R. 5211-46 apply subject to the following modifications: 1° For class II a medical devices, the authorised body veri…
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…
As part of the procedure for the EC declaration of conformity, product quality assurance, for class II b medical devices, the manufacturer must submit an application to the authorized body for assessm…
I.-For the purposes of article L. 162-30-5 of the French Social Security Code, the following are considered to be exceptional: 1° A graft with rare medical indications which, in the indication in ques…
The authorisation shall specify: 1° The organs or tissues or vascularised tissues for which it is granted; 2° The indication or situation concerned; 3° Whether the activity concerns children, adults a…
The national committee provided for in article L. 162-30-5 of the Social Security Code comprises: 1° The Director General of Healthcare or his representative; 2° The Director General of Health or his…
The health care establishment authorised to carry out the activity of exceptional organ or tissue transplantation or composite vascularised tissue transplantation must be able to ensure its implementa…
A visit to check compliance with the safety commitments and rules is carried out by the Regional Health Agency no later than two months after the implementation of the exceptional transplant activity.…
The application for authorisation is sent to the Director General of the Regional Health Agency, by any means which provides a date certain of its receipt, by the health establishment seeking authoris…
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