Article R5211-38
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…
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Showing 7821–7830 of 14711 articles for “Art. 6 oct. 2016”
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…
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.
As part of the procedure applicable to in vitro diagnostic medical devices undergoing an assessment of their performance, the manufacturer must draw up a declaration containing the data enabling the d…
…bound by professional secrecy and discretion under the same conditions as those defined in Article 26 of Title I of the General Statute for Civil Servants in the State and Local Authorities;2° May not…
…ts images from the extract from the authenticated electronic Official Journal No 301 of 28 December 2016 text No 55 at the following address: https://www.legifrance.gouv.fr/jo_pdf.do?id=JORFTEXT000033…
…ts images from the extract from the authenticated electronic Official Journal No 301 of 28 December 2016 text No 55 at the following address: https://www.legifrance.gouv.fr/jo_pdf.do?id=JORFTEXT000033…
…ated in the right-hand column of the same table: Applicable articlesIn the wording resulting fromL. 612-1, with the exception of III, the second to eighth paragraphs of IV, V to VIIIOrder no. 2023-836…
…20 are applicable in New Caledonia and French Polynesia, in their wording resulting from Decree No. 2016-1067 of 3 August 2016, with the exception of III of Article R. 1111-18, subject to the followin…
…e met, to the reporting or public disclosure mechanism provided for in Chapter II of Title I of Law 2016-1691 of 9 December 2016 on transparency, the fight against corruption and the modernisation of…
…clesIn the wording resulting from the decreeR. 131-11 to R. 131-152005-1007 of 2 August 2005R. 131-16 and R. 131-17n° 2011-243 of 4 March 2011R. 131-18n° 2005-1007 of 2 August 2005R. 131-20 and R. 131…
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