Article R5211-46
As part of the EC declaration of conformity procedure, production quality assurance, for active implantable medical devices or medical devices in class IIb or class III, the manufacturer submits an ap…
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Showing 6651–6660 of 51390 articles for “Art. 226-4-2”
As part of the EC declaration of conformity procedure, production quality assurance, for active implantable medical devices or medical devices in class IIb or class III, the manufacturer submits an ap…
As part of the EC declaration of conformity procedure, product quality assurance, the manufacturer shall submit to an authorised body for verification the quality system which he has set up for the fi…
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 b…
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…
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…
For the application of the provisions of this chapter, army hospitals are considered to be public health establishments.
Doctors and dental surgeons who use medical devices on the list provided for in Article R. 5212-36, who carry out their activity outside a health or cosmetic surgery establishment, record the data nec…
Revenue and imprest accounts may be set up under the conditions set out in Decree no. 2019-798 of 26 July 2019 on the revenue and imprest accounts of public bodies.
Placing on the market, whether free of charge or for a consideration, a tattoo product whose container or packaging does not bear one of the indications provided for in article R. 513-10-5 is punishab…
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