Article R5211-23-2
Before applying for the issue of the EC design examination certificate or EC type examination certificate referred to in Articles R. 5211-40 and R. 5211-41 respectively, manufacturers of medical devic…
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Showing 3891–3900 of 13190 articles for “Art. professional status not enough”
Before applying for the issue of the EC design examination certificate or EC type examination certificate referred to in Articles R. 5211-40 and R. 5211-41 respectively, manufacturers of medical devic…
The manufacturer is required to update the risk analysis and management system referred to in Article R. 5211-23-2 by analysing all elements relating to the medical devices he manufactures and taking…
For the purposes of this Title, medical devices other than active implantable medical devices are divided into four classes known as Class I, Class IIa, Class IIb and Class III. Whether a device belon…
If a medical device is intended to be used in conjunction with another medical device, the classification rules apply separately to each device. Computer software controlling a device or influencing i…
…accordance with their intended purpose and under the conditions laid down for that purpose, they do not compromise, directly or indirectly:1° the clinical condition and safety of patients ;2° The heal…
…mplantable medical devices and medical devices manufactured utilising tissues of animal origin, may not be placed on the market or put into service unless they comply with the specific requirements la…
The conditions for implementing the essential requirements defined in this section are specified, on a proposal from the Director General of the Agence nationale de sécurité du médicament et des produ…
At the end of their secondment and if they have not been appointed to a teaching and hospital staff corps, they are reinstated in a hospital practitioner post under the conditions provided for in 3° o…
Candidates appointed as university hospital practitioners, pursuant to article 82 of decree no. 2021-1645 of 13 December 2021 relating to teaching and hospital staff at university hospitals, are simul…
…al or pharmacy students who are nationals of one of the Member States of the European Community or another State party to the Agreement on the European Economic Area who have completed the first six y…
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