Article Annexe I
…if applicable, the chairman of the board of directors;6. Documents justifying the laboratory's sources of funding;7. The organisation chart of the laboratory's staff;8. The full name, position, profe…
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Showing 7621–7630 of 19598 articles for “Art. CE 27-5-1988 n° 62764”
…if applicable, the chairman of the board of directors;6. Documents justifying the laboratory's sources of funding;7. The organisation chart of the laboratory's staff;8. The full name, position, profe…
…he complete application for modification of approval must be sent by post with acknowledgement of receipt, in triplicate, to the public establishment mentioned in article L. 3512-15 of the Public Heal…
…A report describing the activity (number of analyses performed) by category, during the period since the previous approval.Three copies of the completed application for renewal of approval must be s…
…the right-hand column of the same table. APPLICABLE PROVISIONS AS PROVIDED FOR IN L. 5216-11 la loi n° 2019-1461 du 27 décembre 2019 .
Any medical device placed on the market or put into service in France must bear the CE mark certifying that it meets the conditions set out in article R. 5211-17. However, CE marking is not required f…
…PPLICABLE PROVISIONS AS PROVIDED FOR IN L. 1221-1 Law no. 2021-771 of 17 June 2021 ratifying ordinances no. 2021-45 of 20 January 2021 and no. 2021-71 of 27 January 2021 reforming the training of loca…
The CE mark is affixed under the responsibility of the manufacturer or his authorised representative. Its form and dimensions are laid down by order of the Minister for Health. The CE marking must be…
…ity or, failing this, any person responsible for placing the equipment on the market must affix the CE marking, in accordance with the provisions of annex III-6 . The CE marking must be affixed to the…
The CE marking may be affixed to an in vitro diagnostic medical device only if it complies with the essential requirements and has undergone the assessment procedures applicable to it. Where an in vit…
In articles L. 225-25 and L. 225-72, the reference to articles 20 and 21 of law no. 88-1201 of 23 December 1988 relating to undertakings for collective investment in transferable securities and creati…
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